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

Ge Medical Systems Information Technologies — Predicate Candidate Screening

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

74 daysmedian FDA review time

203 days90th percentile

136clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120770	QT GUARD PLUS ANALYSIS SYSTEM	Ge Medical Systems Information Technologies	2012-12-06	267	0
K102426	CARESCAPE MODEL V100 VITAL SIGNS MONITOR	Ge Medical Systems Information Technologies	2010-10-20	56	0
K092369	12SL ECG ANALYSIS PROGRAM	Ge Medical Systems Information Technologies	2010-02-24	203	0
K093141	MARS HOLTER ANALYSIS WORKSTATION	Ge Medical Systems Information Technologies	2009-12-29	85	0
K092027	CARESCAPE MONITOR B850	Ge Medical Systems Information Technologies	2009-08-28	53	9
K090702	MODIFICATION TO DASH 2500 PATIENT MONITOR	Ge Medical Systems Information Technologies	2009-04-15	29	0
K083750	CAPNOSTAT / CAPNOFLEX CO2 SYSTEM	Ge Medical Systems Information Technologies	2009-03-23	96	0
K083639	MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE	Ge Medical Systems Information Technologies	2009-02-17	70	1
K082851	MULTLINK CABLE AND LEADWIRE SYSTEM	Ge Medical Systems Information Technologies	2008-11-19	51	0
K081437	MAC 1600 ECG ANALYSIS SYSTEM	Ge Medical Systems Information Technologies	2008-07-15	54	0
K080251	APEXPRO TELEMETRY SYSTEMS	Ge Medical Systems Information Technologies	2008-06-20	141	3
K080157	DASH 2500 PATIENT MONITOR	Ge Medical Systems Information Technologies	2008-03-24	61	0
K073462	MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIE	Ge Medical Systems Information Technologies	2008-01-11	32	8
K073203	CARESCAPE V100	Ge Medical Systems Information Technologies	2007-11-29	16	0
K072502	MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM	Ge Medical Systems Information Technologies	2007-11-19	74	2
K071982	MODIFICATION TO: UNITY NETWORK ID	Ge Medical Systems Information Technologies	2007-09-21	64	0
K071073	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE	Ge Medical Systems Information Technologies	2007-05-11	25	11
K062976	MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER	Ge Medical Systems Information Technologies	2007-03-16	168	3
K060307	12 RL ALGORITHM	Ge Medical Systems Information Technologies	2006-08-04	178	0
K060833	12SL ECG ANALYSIS PROGRAM	Ge Medical Systems Information Technologies	2006-08-01	127	0
K053356	MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL	Ge Medical Systems Information Technologies	2006-04-19	138	1
K060661	MACTRODE 3	Ge Medical Systems Information Technologies	2006-04-07	25	0
K042782	SEER MC	Ge Medical Systems Information Technologies	2005-09-02	331	0
K051026	MARS HOLTER ANALYSIS WORKSTATION	Ge Medical Systems Information Technologies	2005-07-19	88	0
K051518	UNITY NETWORK ID	Ge Medical Systems Information Technologies	2005-07-08	30	0
K050583	MODEL 250 SERIES MATERNAL/FETAL MONITOR	Ge Medical Systems Information Technologies	2005-06-21	106	0
K051367	PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000	Ge Medical Systems Information Technologies	2005-06-20	26	0
K050731	SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM	Ge Medical Systems Information Technologies	2005-05-19	59	0
K050093	MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM	Ge Medical Systems Information Technologies	2005-05-13	119	4
K050614	MUSE CARDIOLOGY INFORMATION SYSTEM	Ge Medical Systems Information Technologies	2005-04-05	26	1
K043415	CENTRICITY PACS SYSTEM	Ge Medical Systems Information Technologies	2005-01-21	39	16
K042642	AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE	Ge Medical Systems Information Technologies	2004-11-03	37	1
K042525	CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENT	Ge Medical Systems Information Technologies	2004-10-01	14	3
K042177	MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM	Ge Medical Systems Information Technologies	2004-08-27	16	0
K040559	MODIFICATION TO UNITY NETWORK ID	Ge Medical Systems Information Technologies	2004-06-04	93	0
K040458	MODIFICATION TO DASH 3000/4000 PATIENT MONITOR	Ge Medical Systems Information Technologies	2004-06-03	101	0
K033964	SOLAR 9500 INFORMATION MONITOR	Ge Medical Systems Information Technologies	2004-01-15	24	0
K033672	MODIFICATION TO UNITY NETWORK ID	Ge Medical Systems Information Technologies	2003-12-18	24	0
K033492	MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM	Ge Medical Systems Information Technologies	2003-11-24	20	0
K033304	MODIFICATION TO DASH 3000/4000 PATIENT MONITOR	Ge Medical Systems Information Technologies	2003-11-12	29	0
K033365	APEXPRO FH TELEMETRY SYSTEM	Ge Medical Systems Information Technologies	2003-11-06	16	2
K032513	T-WAVE ALTERNANS (TWA) ALGORITHM OPTION	Ge Medical Systems Information Technologies	2003-10-30	77	0
K032577	MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM	Ge Medical Systems Information Technologies	2003-10-10	50	0
K032582	UNITY NETWORK PATIENT DATA SERVER	Ge Medical Systems Information Technologies	2003-09-17	27	0
K032252	MODEL 120 SERIES MATERNAL/FETAL MONITOR	Ge Medical Systems Information Technologies	2003-08-21	30	0
K032369	MODIFICATION TO: APEXPRO TELEMETRY SYSTEM	Ge Medical Systems Information Technologies	2003-08-15	14	3
K032370	CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION	Ge Medical Systems Information Technologies	2003-08-13	12	4
K032346	UNITY NETWORK IS PATIENT VIEWER	Ge Medical Systems Information Technologies	2003-08-05	6	0
K031561	CARDIOSOFT/CASE CARDIAC TESTING SYSTEM	Ge Medical Systems Information Technologies	2003-08-01	74	0
K031376	DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES	Ge Medical Systems Information Technologies	2003-07-16	76	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