ClearanceBrief
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

CodeDeviceRecords
IZISystem, X-Ray, Angiographic55
JAASystem, X-Ray, Fluoroscopic, Image-Intensified22
LNHSystem, Nuclear Magnetic Resonance Imaging14
KPRSystem, X-Ray, Stationary11
LLZSystem, Image Processing, Radiological5
IXRTable, Radiographic, Tilting4
IZLSystem, X-Ray, Mobile4
IXLDevice, Spot-Film3
JAKSystem, X-Ray, Tomography, Computed3
IZWCollimator, Automatic, Radiographic2
MKJAutomated External Defibrillators (Non-Wearable)2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2
DSIDetector And Alarm, Arrhythmia1
IXIBlock, Beam-Shaping, Radiation Therapy1
IZJCamera, X-Ray, Fluorographic, Cine Or Spot1
MOSCoil, Magnetic Resonance, Specialty1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 4, 2013Philips 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
MKJK020715
Jan 4, 2013Philips 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
MKJK050004
Jul 9, 2011Philips 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
JAKK053610
May 19, 2011Philips 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
JAKK053610
Mar 22, 2011Philips 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
IZINone listed
Mar 22, 2011Philips 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
IZIK033737
K041949
Mar 16, 2011Philips Medical Systems North America Co. Phillips
Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
Terminated
IZIK032046
Mar 16, 2011Philips 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
IZIK023441
Mar 16, 2011Philips Medical Systems North America Co. Phillips
Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185.
Terminated
IZIK984545
Mar 16, 2011Philips Medical Systems North America Co. Phillips
Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184.
Terminated
IZIK022899
Mar 8, 2011Philips 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
IXLK010435
Mar 8, 2011Philips 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
IXLK010435
Mar 8, 2011Philips 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
IZLK010762
Mar 1, 2011Philips 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
LNHK041602
Feb 4, 2011Philips 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
LLZK964124
Jan 18, 2011Philips 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
IZIK032046
Jan 18, 2011Philips 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
IZIK023441
Jan 18, 2011Philips 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
IZIK031535
Dec 21, 2010Philips 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
LNHK031815
K041602
Dec 7, 2010Philips 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
IZINone listed
Dec 7, 2010Philips 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
IZINone listed
Dec 7, 2010Philips 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
IZINone listed
Dec 7, 2010Philips 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
IZINone listed
Dec 7, 2010Philips 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
IZINone listed
Dec 7, 2010Philips 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
IZINone listed
Nov 26, 2010Philips 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
KPRK031535
Nov 26, 2010Philips 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
LNHK001796
K031815
Nov 18, 2010Philips 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
LLZK051315
K063093
Oct 25, 2010Philips 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
JAAK010435
Oct 25, 2010Philips 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
JAAK010435
Oct 22, 2010Philips 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
IZIK041949
Oct 22, 2010Philips 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
IZIK041949
Oct 8, 2010Philips 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
DSIK023698
Oct 7, 2010Philips 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
KPRK982795
Oct 7, 2010Philips 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
KPRK945278
Oct 6, 2010Philips 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
KPRK070528
Sep 22, 2010Philips 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
IZIK031333
K033737 +1
Sep 22, 2010Philips 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
IZIK022899
K033737 +1
Sep 22, 2010Philips 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
IZIK022899
Sep 22, 2010Philips 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
IZIK033737
Sep 22, 2010Philips 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
IZIK033737
K984545
Sep 22, 2010Philips 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
IZIK022899
Sep 22, 2010Philips 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
IZIK984545
Sep 22, 2010Philips 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
IZIK984545
Sep 22, 2010Philips 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
IZIK031333
K984545
Sep 22, 2010Philips Medical Systems North America Co. Phillips
Philips BV Endura Mobile X-Ray system with the extended rotation option.
Terminated
JAAK010435
Sep 22, 2010Philips Medical Systems North America Co. Phillips
Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
Terminated
JAAK010435
Sep 22, 2010Philips 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
MOSK052013
Sep 17, 2010Philips 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
LNHK013858
Sep 17, 2010Philips 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
LNHK003853
K011296

Newest 50 of 131.

Get alerts for these product codes