Company ยท US
Philips Medical Systems (Cleveland) Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2017. Name variants (Inc, Corp, punctuation) are merged.
190510(k) clearances (0 in 12 months)
414recalls (0 in 12 months)
404recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 306 |
| KPS | System, Tomography, Computed, Emission | 130 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 61 |
| KPR | System, X-Ray, Stationary | 9 |
| LLZ | System, Image Processing, Radiological | 9 |
| HAW | Neurological Stereotaxic Instrument | 7 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 6 |
| MOS | Coil, Magnetic Resonance, Specialty | 6 |
| MUJ | System, Planning, Radiation Therapy Treatment | 6 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 5 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 |
| IZL | System, X-Ray, Mobile | 4 |
| IYE | Accelerator, Linear, Medical | 3 |
| IYX | Camera, Scintillation (Gamma) | 3 |
| IZH | System, X-Ray, Mammographic | 3 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 3 |
| DXK | Echocardiograph | 2 |
| IXR | Table, Radiographic, Tilting | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2017 | K171850 | Philips CT Big Bore Philips Medical Systems (Cleveland), Inc. | JAK |
| Oct 6, 2017 | K172406 | Ingenuity TF Philips Medical Systems (Cleveland), Inc. | KPS |
| Apr 7, 2017 | K162838 | Philips iCT CT System Philips Medical Systems (Cleveland), Inc. | JAK |
| Apr 5, 2017 | K163711 | IQon Spectral CT Philips Medical Systems (Cleveland), Inc. | JAK |
| Feb 9, 2017 | K170086 | Pinnacle Radiation Therapy Planning System Philips Medical Systems (Cleveland), Inc. | MUJ |
| Aug 8, 2016 | K160743 | Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc. | JAK |
| Apr 8, 2016 | K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer Philips Medical Systems (Cleveland), Inc. | JAK |
| Jun 14, 2013 | K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Philips Medical Systems (Cleveland), Inc. | IYE |
| May 24, 2011 | K111336 | EBW NM 2.0 Philips Medical Systems (Cleveland), Inc. | LLZ |
| Apr 21, 2011 | K111024 | JETPACK 2.0 Philips Medical Systems (Cleveland), Inc. | LLZ |
| Oct 9, 2009 | K092747 | PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL Philips Medical Systems (Cleveland), Inc. | JAK |
| Jun 23, 2009 | K090462 | BRILLIANCE DUAL ENERGY OPTION Philips Medical Systems (Cleveland), Inc. | JAK |
| May 27, 2009 | K091195 | PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 Philips Medical Systems (Cleveland), Inc. | JAK |
| Mar 31, 2009 | K090403 | AUTOSPECT Philips Medical Systems (Cleveland), Inc. | KPS |
| Dec 17, 2008 | K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
| Jun 4, 2008 | K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE Philips Medical Systems (Cleveland), Inc. | KPS |
| Apr 29, 2008 | K081135 | GEMINI CONDOR Philips Medical Systems (Cleveland), Inc. | KPS |
| Apr 11, 2008 | K080927 | BRIGHTVIEW VCT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Jun 5, 2006 | K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc. | JAK |
| Oct 7, 2005 | K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc. | KPS |
| May 23, 2005 | K051170 | GEMINI GXL Philips Medical Systems (Cleveland), Inc. | KPS |
| Nov 9, 2004 | K042935 | GEMINI GXL Philips Medical Systems (Cleveland), Inc. | KPS |
| Oct 29, 2004 | K042839 | C-PET PLUS IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Sep 8, 2004 | K042293 | BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER Philips Medical Systems (Cleveland), Inc. | JAK |
| Jul 29, 2004 | K041955 | GEMINI PET/CT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Feb 20, 2004 | K033677 | BRAIN PERFUSION OPTION Philips Medical Systems (Cleveland), Inc. | JAK |
| Jan 9, 2004 | K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc. | JAK |
| Dec 19, 2003 | K033782 | ALLEGRO IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | KPS |
| Jul 11, 2003 | K032036 | GEMINI 16 Philips Medical Systems (Cleveland), Inc. | KPS |
| Jun 20, 2003 | K031095 | SENSE BODY COIL Philips Medical Systems (Cleveland), Inc. | MOS |
| Feb 10, 2003 | K023785 | LUNG NODULE ASSESSMENT AND COMPARISON OPTION Philips Medical Systems (Cleveland), Inc. | JAK |
| Feb 4, 2003 | K024066 | INFINION SOFTWARE FEATURES Philips Medical Systems (Cleveland), Inc. | LNH |
| Jan 22, 2002 | K013858 | INFINION 0.6T MR IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | LNH |
| Jul 19, 2001 | K011296 | INFINION ENHANCEMENT PACKAGE Philips Medical Systems (Cleveland), Inc. | LNH |
| Jun 15, 2001 | K010817 | MX8000 V5.0 CT SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
| May 8, 2001 | K010691 | BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION Philips Medical Systems (Cleveland), Inc. | LNH |
| Feb 13, 2001 | K003853 | INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 Philips Medical Systems (Cleveland), Inc. | LNH |
| Feb 2, 2001 | K003437 | ODYSSEY LX, MODEL 211320 Philips Medical Systems (Cleveland), Inc. | LLZ |
| Aug 18, 2000 | K002415 | POWERDRIVE 350 OPTION Philips Medical Systems (Cleveland), Inc. | LNH |
| Jun 22, 2000 | K001088 | ULTRASIM CT SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
| Feb 15, 2000 | K000310 | VOYAGER 6.0 SOFTWARE OPTION Philips Medical Systems (Cleveland), Inc. | HAW |
| Oct 8, 1999 | K991256 | VIEWPOINT ENT/ORTHOPEDIC OPTION Philips Medical Systems (Cleveland), Inc. | HAW |
| Oct 7, 1999 | K992335 | BEACON-P, MODEL 211059 Philips Medical Systems (Cleveland), Inc. | KPS |
| Sep 7, 1999 | K992225 | QUANTITATIVE FLOW Philips Medical Systems (Cleveland), Inc. | LNH |
| Aug 23, 1999 | K991943 | MRGP OPTICAL TRACKING UNIT Philips Medical Systems (Cleveland), Inc. | LNH |
| Aug 17, 1999 | K992412 | IPASS BOLUS TRACKING Philips Medical Systems (Cleveland), Inc. | LNH |
| Jul 19, 1999 | K991568 | MR SPECTROSCOPY PACKAGE Philips Medical Systems (Cleveland), Inc. | LNI |
| Jul 8, 1999 | K983764 | VIEWPOINT TOOLS- STERRAD Philips Medical Systems (Cleveland), Inc. | HAW |
| Apr 16, 1999 | K983948 | BEACON, MODEL 211060 Philips Medical Systems (Cleveland), Inc. | KPS |
| Mar 30, 1999 | K990868 | VIEWPOINT PASSIVE TOOL OPTION Philips Medical Systems (Cleveland), Inc. | HAW |
Newest 50 of 190.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2025 | Philips Medical Systems (Cleveland) Inc Pinnacle Radiation Therapy Planning System:
Multimodality Simulation Workspace 18.0.5 Model 870258
UDI code: (01)00884838103566(10)18.0.5.22236
Pinnacle TumorLOC 16.2 Model 870226
UDI code: (01)0088 Open, Classified |
MUJ | K041577 K090808 +1 |
| Aug 1, 2025 | Philips Medical Systems (Cleveland) Inc Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software Open, Classified |
MUJ | K170086 |
| Sep 15, 2022 | Philips Medical Systems (Cleveland) Inc Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. Open, Classified |
MUJ | K170086 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K033254 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K982911 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K033254 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K033254 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K982911 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT
Model # 882446, computed tomography x-ray system Terminated |
JAK | K123599 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT
Model # 882456, computed tomography x-ray system Terminated |
JAK | K172406 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT
Model # 728332, computed tomography x-ray system Terminated |
JAK | K163711 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Brilliance 64
Model # 728231, computed tomography x-ray system Terminated |
JAK | K042293 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc iCT SP
Model # 728311, computed tomography x-ray system Terminated |
JAK | K162838 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc iCT,
Model # 728306, computed tomography x-ray system Terminated |
JAK | K162838 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity Core
Model # 728321, computed tomography x-ray system Terminated |
JAK | K160743 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128
Model # 728323, computed tomography x-ray system Terminated |
JAK | K160743 |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity CT,
Model # 728326, computed tomography x-ray system Terminated |
JAK | K160743 |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView XCT , Model Number 882482 Terminated |
KPS | K080927 |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView X , Model Number 882478 Terminated |
KPS | K080927 |
| Jun 10, 2019 | Philips Medical Systems (Cleveland) Inc BrightView SPECT, Model Number 882480 Terminated |
KPS | K080927 |
| Jun 3, 2019 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT, Model No. 882446
Product Usage:
Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruct Terminated |
KPS | K123599 |
| Dec 19, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT (non-RoHS), Model Number 882456
This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subs Terminated |
KPS | K172406 |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 6 Slice (Air), Model 728256
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data ta Terminated |
JAK | K012009 |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 10 Slice (Air), Model 728251
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data t Terminated |
JAK | K012009 |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Slice (Air), Model 728246
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data t Terminated |
JAK | K012009 |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Slice (Power), Model 728240
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data Terminated |
JAK | K012009 |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 40, Model 728235
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at diff Terminated |
JAK | K033326 |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64, Model 728231
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at dif Terminated |
JAK | K033326 |
| Sep 4, 2018 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT, Software version 2.0.1.
Model Number: 882446
Product Usage:
The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Terminated |
KPS | K123599 |
| Jul 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance iCT, 728306
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different Terminated |
JAK | K162838 |
| Jul 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64, 728231
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different Terminated |
JAK | K033326 |
| Jul 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Air, 728246
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at differ Terminated |
JAK | K012009 |
| May 21, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Digital PET/CT System, Model 882446 with the following UDI's:
(01)00884838059559(21)900004
(01)00884838059559(21)900005
(01)00884838059559(21)900006
(01)00884838059559(21)900007
(01)0088483 Terminated |
KPS | K123599 |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system Terminated |
JAK | K012009 |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system Terminated |
JAK | K012009 |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system Terminated |
JAK | K033326 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128/Elite China 728324 Terminated |
JAK | K160743 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT 882442 Terminated |
KPS | K052640 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128 728323 Terminated |
JAK | K160743 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity Core 728321 Terminated |
JAK | K160743 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Radiology 728244 Terminated |
JAK | K033357 |
| Feb 21, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64 with 4.1.7 XX026 software version model number 728231
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction Terminated |
JAK | K033326 |
| Feb 15, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT, Model No. 882442
Product Usage:
The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of d Terminated |
KPS | K052640 |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon Terminated |
JAK | K012009 |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstructio Terminated |
JAK | K133674 |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction o Terminated |
JAK | K033326 |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reco Terminated |
JAK | K012009 |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by compute Terminated |
JAK | K033357 |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer Terminated |
JAK | K033357 |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstructio Terminated |
JAK | K060937 |
Newest 50 of 414.