Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Philips Medical Systems North America, Inc. · Predicate Candidate Screening

71 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

70 daysmedian FDA review time

198 days90th percentile

71clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K102005	ALLURA XPER OR TABLE SERIES	Philips Medical Systems North America, Inc.	2010-08-09	25	38
K062233	HEARTSTART MRX MONITOR/DEFIBRILLATOR	Philips Medical Systems North America, Inc.	2006-11-22	112	7
K062283	THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 I	Philips Medical Systems North America, Inc.	2006-09-20	44	0
K061052	THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP	Philips Medical Systems North America, Inc.	2006-05-26	39	0
K050151	MULTIDIAGNOST ELEVA	Philips Medical Systems North America, Inc.	2005-02-09	16	15
K042867	PHILIPS ORTHOPAEDIC APPLICATIONS	Philips Medical Systems North America, Inc.	2004-11-02	15	0
K041602	PANORAMA 1.0T	Philips Medical Systems North America, Inc.	2004-07-26	42	7
K033737	ALLURA XPER FD20	Philips Medical Systems North America, Inc.	2003-12-09	11	39
K031333	PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2	Philips Medical Systems North America, Inc.	2003-05-13	15	20
K013894	TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T	Philips Medical Systems North America, Inc.	2002-01-18	56	0
K003459	PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIV	Philips Medical Systems North America, Inc.	2001-01-22	76	0
K003516	GYROSCAN INTERA 3.0T	Philips Medical Systems North America, Inc.	2000-12-27	43	0
K002942	PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORI	Philips Medical Systems North America, Inc.	2000-12-19	89	0
K001796	GYROSCAN INTERA (R7.5)	Philips Medical Systems North America, Inc.	2000-09-06	84	4
K001987	EXPLORER GRADIENT	Philips Medical Systems North America, Inc.	2000-09-06	69	0
K002016	PHILIPS INTEGRIS ALLURA	Philips Medical Systems North America, Inc.	2000-09-06	65	11
K001331	SYNERGY HEAD/NECK COIL	Philips Medical Systems North America, Inc.	2000-06-09	43	0
K000819	PHILIPS CT SECURA MV	Philips Medical Systems North America, Inc.	2000-05-12	60	0
K000832	STEROTACTIC LOCALIZATION DEVICE (SLD)	Philips Medical Systems North America, Inc.	2000-04-27	44	0
K993227	PHILIPS INTURIS DICOM RECORDER	Philips Medical Systems North America, Inc.	1999-12-21	85	0
K990329	PHILIPS EASYVISION WORKSTATION	Philips Medical Systems North America, Inc.	1999-12-07	308	0
K992533	PHILIPS GYROSCAN INTERA (*)	Philips Medical Systems North America, Inc.	1999-10-18	81	0
K990335	PHILIPS EASYVISION WORKSTATION:	Philips Medical Systems North America, Inc.	1999-09-09	218	0
K991765	SYNERGY SHOULDER COIL	Philips Medical Systems North America, Inc.	1999-08-02	70	0
K991278	PHILIPS TOMOSCAN AV-NT	Philips Medical Systems North America, Inc.	1999-05-13	29	0
K984545	RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000,	Philips Medical Systems North America, Inc.	1999-02-25	65	14
K983877	PHILIPS INTEGRIS 3D RA OPTION	Philips Medical Systems North America, Inc.	1998-12-21	49	0
K983821	PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE	Philips Medical Systems North America, Inc.	1998-12-11	43	0
K983140	CT BIOPSYVIEW	Philips Medical Systems North America, Inc.	1998-11-04	57	0
K983069	PHILIPS DUO DIAGNOST	Philips Medical Systems North America, Inc.	1998-11-02	61	1
K982834	RESTGRID PACKAGE/GYROSCAN NT	Philips Medical Systems North America, Inc.	1998-10-29	78	0
K981657	PHILIPS THORAVISION	Philips Medical Systems North America, Inc.	1998-06-18	38	1
K980645	PHILIPS GYROSCAN NT RELEASE 6 SERIES	Philips Medical Systems North America, Inc.	1998-05-11	81	0
K973658	DIFFUSION PACKAGE / GYROSCAN NT	Philips Medical Systems North America, Inc.	1998-05-06	223	0
K974207	PHILIPS EASYVISION WORKSTATION	Philips Medical Systems North America, Inc.	1998-01-22	73	0
K973482	PHILIPS INTEGRIS V5000 AND BV5000	Philips Medical Systems North America, Inc.	1997-11-10	56	4
K972103	PHILIPS EASYVISION	Philips Medical Systems North America, Inc.	1997-09-02	90	0
K971489	RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4	Philips Medical Systems North America, Inc.	1997-07-03	71	0
K971365	PHILIPS INTEGRIS H5000	Philips Medical Systems North America, Inc.	1997-05-14	30	7
K970640	PHILIPS EASY DIAGNOST	Philips Medical Systems North America, Inc.	1997-03-21	29	5
K964318	PHILIPS TOMOSCAN AV EXPANDER UPGRADE	Philips Medical Systems North America, Inc.	1997-01-10	73	0
K963980	PHILIPS EASYVISION	Philips Medical Systems North America, Inc.	1996-12-23	81	1
K960809	PHILIPS SITE VIEW WORKSTATION	Philips Medical Systems North America, Inc.	1996-04-07	39	0
K945945	GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT	Philips Medical Systems North America, Inc.	1995-12-22	382	5
K953910	PHILIPS BV 300 SERIES	Philips Medical Systems North America, Inc.	1995-10-18	58	1
K954255	PHILIPS TOMOSCAN SR 8000	Philips Medical Systems North America, Inc.	1995-10-07	26	0
K945460	PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STA	Philips Medical Systems North America, Inc.	1995-03-14	127	0
K943464	PHILIPS IMPROVED CHECK RADIOGRAPH OPTION	Philips Medical Systems North America, Inc.	1995-02-01	198	0
K945278	PHILIPS BUCKY DIAGNOST FAMILY	Philips Medical Systems North America, Inc.	1994-12-14	47	7
K944326	PHILIPS TOMOSCAN SR5000	Philips Medical Systems North America, Inc.	1994-10-21	53	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