Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Medical Systems (Cleveland), Inc. — Predicate Candidate Screening
190 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
170 days90th percentile
190clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171850 | Philips CT Big Bore | Philips Medical Systems (Cleveland), Inc. | 2017-11-09 | 141 | 5 |
| K172406 | Ingenuity TF | Philips Medical Systems (Cleveland), Inc. | 2017-10-06 | 58 | 1 |
| K162838 | Philips iCT CT System | Philips Medical Systems (Cleveland), Inc. | 2017-04-07 | 178 | 3 |
| K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017-04-05 | 96 | 2 |
| K170086 | Pinnacle Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | 2017-02-09 | 30 | 3 |
| K160743 | Philips Ingenuity CT | Philips Medical Systems (Cleveland), Inc. | 2016-08-08 | 144 | 5 |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | Philips Medical Systems (Cleveland), Inc. | 2016-04-08 | 133 | 0 |
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2013-06-14 | 65 | 1 |
| K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011-05-24 | 12 | 0 |
| K111024 | JETPACK 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011-04-21 | 9 | 0 |
| K092747 | PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESS | Philips Medical Systems (Cleveland), Inc. | 2009-10-09 | 31 | 0 |
| K090462 | BRILLIANCE DUAL ENERGY OPTION | Philips Medical Systems (Cleveland), Inc. | 2009-06-23 | 120 | 0 |
| K091195 | PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 | Philips Medical Systems (Cleveland), Inc. | 2009-05-27 | 34 | 5 |
| K090403 | AUTOSPECT | Philips Medical Systems (Cleveland), Inc. | 2009-03-31 | 42 | 0 |
| K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2008-12-17 | 22 | 5 |
| K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE | Philips Medical Systems (Cleveland), Inc. | 2008-06-04 | 14 | 0 |
| K081135 | GEMINI CONDOR | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 | 8 | 12 |
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2008-04-11 | 9 | 22 |
| K060937 | BRILLIANCE VOLUME | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 | 61 | 40 |
| K052640 | GEMINI RAPTOR | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 | 11 | 30 |
| K051170 | GEMINI GXL | Philips Medical Systems (Cleveland), Inc. | 2005-05-23 | 17 | 10 |
| K042935 | GEMINI GXL | Philips Medical Systems (Cleveland), Inc. | 2004-11-09 | 15 | 2 |
| K042839 | C-PET PLUS IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2004-10-29 | 15 | 0 |
| K042293 | BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER | Philips Medical Systems (Cleveland), Inc. | 2004-09-08 | 15 | 1 |
| K041955 | GEMINI PET/CT IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2004-07-29 | 8 | 2 |
| K033677 | BRAIN PERFUSION OPTION | Philips Medical Systems (Cleveland), Inc. | 2004-02-20 | 88 | 0 |
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 | Philips Medical Systems (Cleveland), Inc. | 2004-01-09 | 81 | 34 |
| K033782 | ALLEGRO IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2003-12-19 | 15 | 0 |
| K032036 | GEMINI 16 | Philips Medical Systems (Cleveland), Inc. | 2003-07-11 | 10 | 2 |
| K031095 | SENSE BODY COIL | Philips Medical Systems (Cleveland), Inc. | 2003-06-20 | 74 | 0 |
| K023785 | LUNG NODULE ASSESSMENT AND COMPARISON OPTION | Philips Medical Systems (Cleveland), Inc. | 2003-02-10 | 90 | 0 |
| K024066 | INFINION SOFTWARE FEATURES | Philips Medical Systems (Cleveland), Inc. | 2003-02-04 | 57 | 0 |
| K013858 | INFINION 0.6T MR IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2002-01-22 | 62 | 2 |
| K011296 | INFINION ENHANCEMENT PACKAGE | Philips Medical Systems (Cleveland), Inc. | 2001-07-19 | 80 | 3 |
| K010817 | MX8000 V5.0 CT SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2001-06-15 | 88 | 11 |
| K010691 | BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION | Philips Medical Systems (Cleveland), Inc. | 2001-05-08 | 61 | 0 |
| K003853 | INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 | Philips Medical Systems (Cleveland), Inc. | 2001-02-13 | 63 | 6 |
| K003437 | ODYSSEY LX, MODEL 211320 | Philips Medical Systems (Cleveland), Inc. | 2001-02-02 | 88 | 1 |
| K002415 | POWERDRIVE 350 OPTION | Philips Medical Systems (Cleveland), Inc. | 2000-08-18 | 10 | 0 |
| K001088 | ULTRASIM CT SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2000-06-22 | 79 | 1 |
| K000310 | VOYAGER 6.0 SOFTWARE OPTION | Philips Medical Systems (Cleveland), Inc. | 2000-02-15 | 14 | 0 |
| K991256 | VIEWPOINT ENT/ORTHOPEDIC OPTION | Philips Medical Systems (Cleveland), Inc. | 1999-10-08 | 178 | 0 |
| K992335 | BEACON-P, MODEL 211059 | Philips Medical Systems (Cleveland), Inc. | 1999-10-07 | 86 | 0 |
| K992225 | QUANTITATIVE FLOW | Philips Medical Systems (Cleveland), Inc. | 1999-09-07 | 67 | 0 |
| K991943 | MRGP OPTICAL TRACKING UNIT | Philips Medical Systems (Cleveland), Inc. | 1999-08-23 | 75 | 0 |
| K992412 | IPASS BOLUS TRACKING | Philips Medical Systems (Cleveland), Inc. | 1999-08-17 | 28 | 0 |
| K991568 | MR SPECTROSCOPY PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 | 75 | 0 |
| K983764 | VIEWPOINT TOOLS- STERRAD | Philips Medical Systems (Cleveland), Inc. | 1999-07-08 | 255 | 0 |
| K983948 | BEACON, MODEL 211060 | Philips Medical Systems (Cleveland), Inc. | 1999-04-16 | 162 | 0 |
| K990860 | VIEWPOINT MICROSCOPE OPTION | Philips Medical Systems (Cleveland), Inc. | 1999-03-30 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda