Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GE Medical Systems SCS — Predicate Candidate Screening

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

120 daysmedian FDA review time

343 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253770	CardIQ Suite	GE Medical Systems SCS	2026-07-21	237	0
K260087	Senographe Pristina; SenoBright HD; Pristina Serena; Pristin	GE Medical Systems SCS	2026-03-24	71	0
K251199	Allia Moveo	GE Medical Systems SCS	2025-12-09	235	1
K243672	CardIQ Suite	GE Medical Systems SCS	2025-06-18	203	0
K243651	VersaViewer	GE Medical Systems SCS	2025-04-21	146	0
K243446	3DXR	GE Medical Systems SCS	2025-02-25	111	0
K233731	CardIQ Suite	GE Medical Systems SCS	2024-08-01	254	0
K233714	BreView	GE Medical Systems SCS	2024-01-25	66	0
K232344	Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR	GE Medical Systems SCS	2023-10-11	68	7
K223424	Spine Auto Views	GE Medical Systems SCS	2023-07-13	241	0
K223490	FlightPlan for Embolization	GE Medical Systems SCS	2023-03-21	120	0
K223152	Vision 2, EVARVision, TrackVision 2, HeartVision 2	GE Medical Systems SCS	2022-11-22	47	0
K222895	DynamicIQ	GE Medical Systems SCS	2022-11-22	60	0
K211180	Liver Suite	GE Medical Systems SCS	2022-05-02	377	0
K213725	CardIQ Suite	GE Medical Systems SCS	2022-03-11	105	0
K210807	FlightPlan for Liver	GE Medical Systems SCS	2021-10-22	219	0
K211247	PET VCAR	GE Medical Systems SCS	2021-07-27	92	0
K200626	VesselIQ Xpress	GE Medical Systems SCS	2021-02-16	343	0
K193306	PROView	GE Medical Systems SCS	2020-11-17	354	0
K193289	FastStroke, CT Perfusion 4D	GE Medical Systems SCS	2020-11-12	351	0
K193281	Hepatic VCAR	GE Medical Systems SCS	2020-03-20	114	0
K192277	CardIQ Flow	GE Medical Systems SCS	2020-02-14	176	0
K193261	FlightPlan for Embolization	GE Medical Systems SCS	2020-01-24	59	0
K183204	Bone VCAR (BVCAR)	GE Medical Systems SCS	2019-04-08	140	0
K183210	Thoracic VCAR with GSI Pulmonary Perfusion	GE Medical Systems SCS	2019-03-29	130	0
K180225	GSI Viewer with GSI Fat Option	GE Medical Systems SCS	2018-04-24	88	0
K152352	Stereo 3D option for Vision Applications	GE Medical Systems SCS	2016-01-20	153	0
K152584	Stroke VCAR	GE Medical Systems SCS	2016-01-20	132	0
K133278	DISCOVERY IGS 740	GE Medical Systems SCS	2014-04-24	182	5
K133649	HEPATIC VCAR	GE Medical Systems SCS	2014-04-22	146	0
K131885	SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)	GE Medical Systems SCS	2013-09-26	93	0
K121827	GSI VIEWER WITH VUE OPTION	GE Medical Systems SCS	2012-09-13	84	0
K122164	MR VESSELLQ XPRESS	GE Medical Systems SCS	2012-09-07	49	0
K120910	CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS	GE Medical Systems SCS	2012-06-18	84	0
K113403	GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM	GE Medical Systems SCS	2012-02-14	89	4
K092639	INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18	GE Medical Systems SCS	2009-12-02	97	0
K093234	INTEGRATED REGISTRATION	GE Medical Systems SCS	2009-10-30	15	0
K073153	CARDIQ FUNCTION XPRESS	GE Medical Systems SCS	2008-02-26	110	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