Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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