Company ยท US
Philips Medical Systems North America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2010. Name variants (Inc, Corp, punctuation) are merged.
95510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 19 |
| LLZ | System, Image Processing, Radiological | 16 |
| JAK | System, X-Ray, Tomography, Computed | 10 |
| IZI | System, X-Ray, Angiographic | 9 |
| OWB | Interventional Fluoroscopic X-Ray System | 5 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 4 |
| KPR | System, X-Ray, Stationary | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 3 |
| MOS | Coil, Magnetic Resonance, Specialty | 3 |
| IYE | Accelerator, Linear, Medical | 2 |
| IZH | System, X-Ray, Mammographic | 2 |
| IZL | System, X-Ray, Mobile | 2 |
| DQA | Oximeter | 1 |
| DXK | Echocardiograph | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| IWE | Monitor, Patient Position, Light-Beam | 1 |
| IXR | Table, Radiographic, Tilting | 1 |
| IZF | System, X-Ray, Tomographic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2010 | K101311 | EP NAVIGATOR R3 Philips Medical Systems North America Co. | LLZ |
| Aug 9, 2010 | K102005 | ALLURA XPER OR TABLE SERIES Philips Medical Systems North America, Inc. | OWB |
| Mar 24, 2009 | K090625 | WIRELESS PORTABLE DETECTOR FD-W17 Philips Medical Systems North America Co. | MQB |
| Mar 16, 2009 | K090590 | VERADIUS, MODEL 718-130 Philips Medical Systems North America Co. | OWB |
| Oct 8, 2008 | K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR Philips Medical Systems North America Co. | MHX |
| Jan 5, 2007 | K063781 | PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE Philips Medical Systems North America Co. | LLZ |
| Nov 22, 2006 | K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR Philips Medical Systems North America, Inc. | MKJ |
| Oct 18, 2006 | K062268 | MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 Philips Medical Systems North America Co. | DQA |
| Sep 20, 2006 | K062283 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS Philips Medical Systems North America, Inc., DE | MHX |
| Sep 15, 2006 | K061685 | PULSERA Philips Medical Systems North America Co. | IZL |
| Sep 6, 2006 | K061995 | XCELERA Philips Medical Systems North America Co. | LLZ |
| May 26, 2006 | K061052 | THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 Philips Medical Systems North America, Inc., DE | MHX |
| Apr 4, 2006 | K060749 | XPERCT Philips Medical Systems North America Co. | IZI |
| Apr 8, 2005 | K050692 | FLXIS Philips Medical Systems North America Co. | JAA |
| Feb 15, 2005 | K043147 | ACHIEVA FAMILY Philips Medical Systems North America Co. | LNH |
| Feb 9, 2005 | K050151 | MULTIDIAGNOST ELEVA Philips Medical Systems North America, Inc. | KPR |
| Nov 2, 2004 | K042867 | PHILIPS ORTHOPAEDIC APPLICATIONS Philips Medical Systems North America, Inc. | LLZ |
| Oct 4, 2004 | K042368 | PRACTIX CONVENIO Philips Medical Systems North America Co. | IZL |
| Sep 27, 2004 | K042334 | ALLURA 3D-CA, RELEASE 1 Philips Medical Systems North America Co. | LLZ |
| Jul 30, 2004 | K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., NL | IZI |
| Jul 26, 2004 | K041602 | PANORAMA 1.0T Philips Medical Systems North America, Inc. | LNH |
| Feb 19, 2004 | K040254 | INTEGRIS 3D-RA, RELEASE 4.2 Philips Medical Systems North America Co. | LLZ |
| Dec 9, 2003 | K033737 | ALLURA XPER FD20 Philips Medical Systems North America, Inc., NL | OWB |
| Aug 14, 2003 | K031836 | PHILIPS FRESCO RELEASE 1 Philips Medical Systems North America Co. | LLZ |
| Jul 21, 2003 | K031597 | DUNLEE FORMAT COLLIMATOR FAMILY Philips Medical Systems North America Co. | IZW |
| Jun 17, 2003 | K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co. | KPR |
| May 13, 2003 | K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., NL | IZI |
| Mar 6, 2003 | K030520 | INTERA FAMILY Philips Medical Systems North America Co. | LNH |
| Dec 19, 2002 | K023137 | PHILIPS EASYVISION WORKSTATION RELEASE 6 Philips Medical Systems North America Co. | LLZ |
| Nov 22, 2002 | K022899 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 Philips Medical Systems North America Co. | JAA |
| Oct 25, 2002 | K022788 | PHILIPS HARMONY RELEASE 1 Philips Medical Systems North America Co. | LLZ |
| Jan 18, 2002 | K013894 | TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T Philips Medical Systems North America, Inc. | MOS |
| Dec 11, 2001 | K013344 | INTERA I/T Philips Medical Systems North America Co. | LNH |
| Oct 1, 2001 | K012238 | DOSERIGHT Philips Medical Systems North America Co. | JAK |
| Jan 22, 2001 | K003459 | PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW Philips Medical Systems North America, Inc. | LLZ |
| Dec 27, 2000 | K003516 | GYROSCAN INTERA 3.0T Philips Medical Systems North America, Inc. | LNH |
| Dec 19, 2000 | K002942 | PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING Philips Medical Systems North America, Inc. | LLZ |
| Sep 6, 2000 | K002016 | PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc., NL | OWB |
| Sep 6, 2000 | K001987 | EXPLORER GRADIENT Philips Medical Systems North America, Inc. | LNH |
| Sep 6, 2000 | K001796 | GYROSCAN INTERA (R7.5) Philips Medical Systems North America, Inc. | LNH |
| Jun 9, 2000 | K001331 | SYNERGY HEAD/NECK COIL Philips Medical Systems North America, Inc. | MOS |
| May 12, 2000 | K000819 | PHILIPS CT SECURA MV Philips Medical Systems North America, Inc. | JAK |
| Apr 27, 2000 | K000832 | STEROTACTIC LOCALIZATION DEVICE (SLD) Philips Medical Systems North America, Inc. | LNH |
| Dec 21, 1999 | K993227 | PHILIPS INTURIS DICOM RECORDER Philips Medical Systems North America, Inc. | LLZ |
| Dec 7, 1999 | K990329 | PHILIPS EASYVISION WORKSTATION Philips Medical Systems North America, Inc. | LNH |
| Oct 18, 1999 | K992533 | PHILIPS GYROSCAN INTERA (*) Philips Medical Systems North America, Inc. | LNH |
| Sep 9, 1999 | K990335 | PHILIPS EASYVISION WORKSTATION: Philips Medical Systems North America, Inc. | LNH |
| Aug 2, 1999 | K991765 | SYNERGY SHOULDER COIL Philips Medical Systems North America, Inc. | MOS |
| May 13, 1999 | K991278 | PHILIPS TOMOSCAN AV-NT Philips Medical Systems North America, Inc. | JAK |
| Feb 25, 1999 | K984545 | RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS Philips Medical Systems North America, Inc., NL | IZI |
Newest 50 of 95.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Philips Medical Systems North America Inc. Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206
EPIQ is intended fo Terminated |
IYN | K132304 |
| Mar 20, 2014 | Philips Medical Systems North America Inc. Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206
EPIQ is intended fo Terminated |
IYN | K132304 |
| Mar 19, 2014 | Philips Medical Systems North America Inc. Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389.
The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders Terminated |
MKJ | K111693 |
| Mar 19, 2014 | Philips Medical Systems North America Inc. Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs).
Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who Terminated |
MKJ | K020715 K040904 |
| Nov 20, 2013 | Philips Medical Systems North America Inc. EPIQ 7 Ultrasound System, Model 795200, 795201, 795202.
Intended for diagnostic ultrasound imaging and fluid flow analysis. Terminated |
IYN | K132304 |