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

Ge Medical Systems F.I. Haifa · Predicate Candidate Screening

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

25 daysmedian FDA review time

90 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K130884	XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION	Ge Medical Systems F.I. Haifa	2013-04-12	14	0
K093982	XELERIS 3 PROCESSING AND REVIEW WORKSTATION	Ge Medical Systems F.I. Haifa	2010-01-08	15	1
K093514	DISCOVERY MODEL NM/CT 670	Ge Medical Systems F.I. Haifa	2009-12-10	27	10
K083504	GE DISCOVERY NM/CT 570C	Ge Medical Systems F.I. Haifa	2008-12-12	16	0
K080124	VENTRI 1.1	Ge Medical Systems F.I. Haifa	2008-01-31	14	2
K051855	VENTRI	Ge Medical Systems F.I. Haifa	2005-08-02	25	3
K043381	INFINIA LIGHTSPEED	Ge Medical Systems F.I. Haifa	2004-12-23	14	0
K033874	MYOLIGHT	Ge Medical Systems F.I. Haifa	2003-12-30	15	0
K023932	GE PHOTON ENERGY RECOVERY (PER) OPTION	Ge Medical Systems F.I. Haifa	2002-12-11	15	0
K022960	GE QUASAR NUCLEAR MEDICINE SYSTEM	Ge Medical Systems F.I. Haifa	2002-09-19	13	24
K003264	QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATIO	Ge Medical Systems F.I. Haifa	2000-12-21	64	0
K000395	EINSTEIN PROCESSING AND REVIEW WORKSTATION	Ge Medical Systems F.I. Haifa	2000-05-03	86	0
K994167	CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABL	Ge Medical Systems F.I. Haifa	2000-03-07	89	0
K991841	HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA	Ge Medical Systems F.I. Haifa	1999-08-26	90	8
K991896	MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE	Ge Medical Systems F.I. Haifa	1999-08-23	81	0
K981352	VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9	Ge Medical Systems F.I. Haifa	1998-07-13	90	0
K980959	VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIA	Ge Medical Systems F.I. Haifa	1998-06-04	82	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