Company
Philips Medical Systems North America Co. Phillips
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
131recalls (0 in 12 months)
111recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IZI | System, X-Ray, Angiographic | 55 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 22 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 14 |
| KPR | System, X-Ray, Stationary | 11 |
| LLZ | System, Image Processing, Radiological | 5 |
| IXR | Table, Radiographic, Tilting | 4 |
| IZL | System, X-Ray, Mobile | 4 |
| IXL | Device, Spot-Film | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 |
| IZW | Collimator, Automatic, Radiographic | 2 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 |
| DSI | Detector And Alarm, Arrhythmia | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2013 | Philips Medical Systems North America Co. Phillips Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 Terminated |
MKJ | K020715 |
| Jan 4, 2013 | Philips Medical Systems North America Co. Phillips Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305
The FRx Defibrillator is intended to trea Terminated |
MKJ | K050004 |
| Jul 9, 2011 | Philips Medical Systems North America Co. Phillips The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument.
The Tool Terminated |
JAK | K053610 |
| May 19, 2011 | Philips Medical Systems North America Co. Phillips PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911.
Designed to be used only with the PercuNav" image guided intervention system. The Field Generator St Terminated |
JAK | K053610 |
| Mar 22, 2011 | Philips Medical Systems North America Co. Phillips Allura XPER FD 20 and and Allura CV20;
Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20.
Angiographic X-ray systems with a solid state X-ray imaging device for c Terminated |
IZI | None listed |
| Mar 22, 2011 | Philips Medical Systems North America Co. Phillips Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20.
Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and Terminated |
IZI | K033737 K041949 |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115. Terminated |
IZI | K032046 |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO 70800114. Terminated |
IZI | K023441 |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185. Terminated |
IZI | K984545 |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184. Terminated |
IZI | K022899 |
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera, Rel. 2.3, 718095.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Terminated |
IXL | K010435 |
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Endura, Rel. 2, 718074.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Terminated |
IXL | K010435 |
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Libra, Mobile X-ray unit, 718022.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic
techniques in a wide variety surgical and non-surgical applications including; cerebral, Terminated |
IZL | K010762 |
| Mar 1, 2011 | Philips Medical Systems North America Co. Phillips The Panorama HFO system has the Traceable Item Identification (12NC):
9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO).
9896 030 19641-SW R 2.5.3
9896 030 19861-SW R 2.6.1
9 Terminated |
LNH | K041602 |
| Feb 4, 2011 | Philips Medical Systems North America Co. Phillips PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V".
Provides on Terminated |
LLZ | K964124 |
| Jan 18, 2011 | Philips Medical Systems North America Co. Phillips Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system.
The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventiona Terminated |
IZI | K032046 |
| Jan 18, 2011 | Philips Medical Systems North America Co. Phillips Philips MultiDiagnost Eleva with Digital Image (DI) Rel.2 system.
The Philips MultiDiagnost Eleva is intended use as a multi-functional universal system, general RF, Fluoroscopy, Radiography and Angi Terminated |
IZI | K023441 |
| Jan 18, 2011 | Philips Medical Systems North America Co. Phillips Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system.
The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/univers Terminated |
IZI | K031535 |
| Dec 21, 2010 | Philips Medical Systems North America Co. Phillips Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit.
Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orie Terminated |
LNH | K031815 K041602 |
| Dec 7, 2010 | Philips Medical Systems North America Co. Phillips ALLURA XPER FD20/10
The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular Terminated |
IZI | None listed |
| Dec 7, 2010 | Philips Medical Systems North America Co. Phillips ALLURA XPER FD20
The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular dia Terminated |
IZI | None listed |
| Dec 7, 2010 | Philips Medical Systems North America Co. Phillips ALLURA XPER FD10/10
The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular Terminated |
IZI | None listed |
| Dec 7, 2010 | Philips Medical Systems North America Co. Phillips Allura XPER FD10 F/C
The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular Terminated |
IZI | None listed |
| Dec 7, 2010 | Philips Medical Systems North America Co. Phillips Allura XPER X-ray system.
The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vas Terminated |
IZI | None listed |
| Dec 7, 2010 | Philips Medical Systems North America Co. Phillips MultiDiagnost Eleva with FD.
The Philips MultiDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/ universal system, general R/F, Fluoroscop Terminated |
IZI | None listed |
| Nov 26, 2010 | Philips Medical Systems North America Co. Phillips Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany. Terminated |
KPR | K031535 |
| Nov 26, 2010 | Philips Medical Systems North America Co. Phillips The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems".
The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the dr Terminated |
LNH | K001796 K031815 |
| Nov 18, 2010 | Philips Medical Systems North America Co. Phillips Philips EasyVision MM workstation with software R10.2 and R11.1
The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images f Terminated |
LLZ | K051315 K063093 |
| Oct 25, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device b Terminated |
JAA | K010435 |
| Oct 25, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device Terminated |
JAA | K010435 |
| Oct 22, 2010 | Philips Medical Systems North America Co. Phillips Allura Xper FD10/10 Biplane X-ray system.
Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement Terminated |
IZI | K041949 |
| Oct 22, 2010 | Philips Medical Systems North America Co. Phillips Allura Xper FD10 Monoplane X-ray system.
Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement a Terminated |
IZI | K041949 |
| Oct 8, 2010 | Philips Medical Systems North America Co. Phillips The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems".
The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm m Terminated |
DSI | K023698 |
| Oct 7, 2010 | Philips Medical Systems North America Co. Phillips The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during th Terminated |
KPR | K982795 |
| Oct 7, 2010 | Philips Medical Systems North America Co. Phillips The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the e Terminated |
KPR | K945278 |
| Oct 6, 2010 | Philips Medical Systems North America Co. Phillips Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
It is designed for Terminated |
KPR | K070528 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane.
The BIPLANE system has two C-arms and it allows the operator to im Terminated |
IZI | K031333 K033737 +1 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane.
The Monoplane system has one C-arm and it c Terminated |
IZI | K022899 K033737 +1 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris Allura Flat Detector 9C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabine Terminated |
IZI | K022899 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER FD20 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabinet).
Intended use Terminated |
IZI | K033737 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER FD 20/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Terminated |
IZI | K033737 K984545 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use fo Terminated |
IZI | K022899 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris BH5000 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Angio Terminated |
IZI | K984545 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris H5000F Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Angio Terminated |
IZI | K984545 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Ang Terminated |
IZI | K031333 K984545 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Endura Mobile X-Ray system with the extended rotation option. Terminated |
JAA | K010435 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera Mobile X-Ray system with the extended rotation option. Terminated |
JAA | K010435 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x. Terminated |
MOS | K052013 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143 Terminated |
LNH | K013858 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Infinion is Nuclear Magnetic Resonance Imaging. Philips Infinion 1.5T System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.. Terminated |
LNH | K003853 K011296 |
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