Medical Device Manufacturer · US , Shelton , CT

Philips Medical Systems North America, Inc.

71 submissions · 71 cleared · Since 1989
71
Total
71
Cleared
0
Denied

Philips Medical Systems North America, Inc. — FDA 510(k) Submissions

Philips Medical Systems North America, Inc. has submitted 71 FDA 510(k) premarket notifications since 1989, of which 71 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Nuclear Magnetic Resonance Imaging, System, X-ray, Tomography, Computed, System, Image Processing, Radiological, System, X-ray, Angiographic, Interventional Fluoroscopic X-ray System . Use the specialty filter in the sidebar to narrow results.

71 devices
1–25 of 71
ALLURA XPER OR TABLE SERIES
K102005 · OWB Interventional... · Radiology
Aug 2010 25d
HEARTSTART MRX MONITOR/DEFIBRILLATOR
K062233 · MKJ Automated External... · Cardiovascular
Nov 2006 112d
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
K062283 · MHX Monitor, Physiological,... · Cardiovascular
Sep 2006 44d
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
K061052 · MHX Monitor, Physiological,... · Cardiovascular
May 2006 39d
MULTIDIAGNOST ELEVA
K050151 · KPR System, X-ray, Stationary · Radiology
Feb 2005 16d
PHILIPS ORTHOPAEDIC APPLICATIONS
K042867 · LLZ System, Image Processing,... · Radiology
Nov 2004 15d
PANORAMA 1.0T
K041602 · LNH System, Nuclear Magnetic... · Radiology
Jul 2004 42d
ALLURA XPER FD20
K033737 · OWB Interventional... · Radiology
Dec 2003 11d
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
K031333 · IZI System, X-ray, Angiographic · Radiology
May 2003 15d
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894 · MOS Coil, Magnetic Resonance,... · Radiology
Jan 2002 56d
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · LLZ System, Image Processing,... · Radiology
Jan 2001 76d
GYROSCAN INTERA 3.0T
K003516 · LNH System, Nuclear Magnetic... · Radiology
Dec 2000 43d
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
K002942 · LLZ System, Image Processing,... · Radiology
Dec 2000 89d
GYROSCAN INTERA (R7.5)
K001796 · LNH System, Nuclear Magnetic... · Radiology
Sep 2000 84d
EXPLORER GRADIENT
K001987 · LNH System, Nuclear Magnetic... · Radiology
Sep 2000 69d
PHILIPS INTEGRIS ALLURA
K002016 · OWB Interventional... · Radiology
Sep 2000 65d
SYNERGY HEAD/NECK COIL
K001331 · MOS Coil, Magnetic Resonance,... · Radiology
Jun 2000 43d
PHILIPS CT SECURA MV
K000819 · JAK System, X-ray,... · Radiology
May 2000 60d
STEROTACTIC LOCALIZATION DEVICE (SLD)
K000832 · LNH System, Nuclear Magnetic... · Radiology
Apr 2000 44d
PHILIPS INTURIS DICOM RECORDER
K993227 · LLZ System, Image Processing,... · Radiology
Dec 1999 85d
PHILIPS EASYVISION WORKSTATION
K990329 · LNH System, Nuclear Magnetic... · Radiology
Dec 1999 308d
PHILIPS GYROSCAN INTERA (*)
K992533 · LNH System, Nuclear Magnetic... · Radiology
Oct 1999 81d
PHILIPS EASYVISION WORKSTATION:
K990335 · LNH System, Nuclear Magnetic... · Radiology
Sep 1999 218d
SYNERGY SHOULDER COIL
K991765 · MOS Coil, Magnetic Resonance,... · Radiology
Aug 1999 70d
PHILIPS TOMOSCAN AV-NT
K991278 · JAK System, X-ray,... · Radiology
May 1999 29d
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