FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

197 results for "Philips Medical Systems (Cleveland), Inc."
1–24 of 197
Search insights Median review: 74d Cleared: 100% Top manufacturer: Philips Medical Systems (Cleveland), Inc. Lead specialty: Radiology
Cleared Apr 04, 2018
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
K173079 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 187d
Cleared Jan 22, 2018
3D APT
K172920 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Nov 09, 2017
Philips CT Big Bore
K171850 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 141d
Cleared Oct 06, 2017
Ingenuity TF
K172406 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 58d
Cleared Apr 07, 2017
Philips iCT CT System
K162838 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 178d
Cleared Apr 05, 2017
IQon Spectral CT
K163711 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 96d
Cleared Feb 09, 2017
Pinnacle Radiation Therapy Planning System
K170086 · MUJ
Philips Medical Systems (Cleveland),...
Radiology · 30d
Cleared Dec 30, 2016
MultiBand SENSE
K162940 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 70d
Cleared Aug 08, 2016
Philips Ingenuity CT
K160743 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 144d
Cleared Apr 08, 2016
Philips Multislice CT System with Low Dose CT Lung Cancer
K153444 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 133d
Cleared Aug 07, 2015
Philips Spectral CT Applications
K150665 · JAK
Philips Medical Systems Nethrlands BV
Radiology · 144d
Cleared May 08, 2015
MultiBand SENSE
K143606 · LNH
Philips Medical Systems Nethrlands BV
Radiology · 140d
Cleared Apr 09, 2015
O-MAR
K143253 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Mar 20, 2015
mDIXON XD
K143128 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 141d
Cleared Jun 14, 2013
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K130992 · IYE
Philips Medical Systems (Cleveland),...
Radiology · 65d
Cleared May 24, 2011
EBW NM 2.0
K111336 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 12d
Cleared Apr 21, 2011
JETPACK 2.0
K111024 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 9d
Cleared Oct 09, 2009
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 31d
Cleared Jun 23, 2009
BRILLIANCE DUAL ENERGY OPTION
K090462 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 120d
Cleared May 27, 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
K091195 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared Mar 31, 2009
AUTOSPECT
K090403 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 42d
Cleared Dec 17, 2008
PHILIPS MODEL MX 16 SLICE CT SYSTEM
K083498 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 22d
Cleared Jun 04, 2008
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
K081426 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 14d
Cleared Apr 29, 2008
GEMINI CONDOR
K081135 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 8d