510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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General Electric Co.

Milwaukee, WI, US

General Electric Co. appears in FDA device records in Milwaukee, WI. FDA records list 256 510(k) clearances between and , 16 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
256
PMA records
16
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 256

FDA records hold 256 510(k) clearances for General Electric Co. between 1976 and 2011. The busiest year on record is 1981, with 26. The most recent is 2011, with 3.

Clearances by year, as a table
510(k) clearance decisions for General Electric Co., by decision year
YearClearances
19767
197714
197811
19796
198019
198126
198216
19832
19849
19859
198613
198712
198812
19898
19905
19915
199210
19933
19946
19956
19963
19972
19983
19992
20015
20024
200311
20046
20055
20066
20075
20082
20113
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIALMUESubstantially Equivalent
K103485SENOGRAPH DS, SENOGRAPH ESSENSTIALMUESubstantially Equivalent
K103489GE VEO RECONSTRUCTION OPTIONJAKSubstantially Equivalent
K082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONKGISubstantially Equivalent
K081921GE VIVID E9 ULTRASOUNDIYNSubstantially Equivalent
K073297GE LOGIQ P6IYNSubstantially Equivalent
K072952GE ECHOPACLLZSubstantially Equivalent
K072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUNDIYOSubstantially Equivalent
K072075MODIFICATION TO GE LOGIQ A3IYNSubstantially Equivalent
K071985GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUNDIYNSubstantially Equivalent
K063006GE LOGIQ WORKSLLZSubstantially Equivalent
K061682GE VOLUSON E8 ULTRASOUND SYSTEMIYOSubstantially Equivalent
K061525GE VIVID - IIYNSubstantially Equivalent
K061129GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000IYNSubstantially Equivalent
K060993GE LOGIQ P5 AND A5IYNSubstantially Equivalent
K060542GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XXIYNSubstantially Equivalent
K053435GE VOLUSON IIYNSubstantially Equivalent
K052441GE LOGIQ 7 ULTRASOUND BT05IYNSubstantially Equivalent
K050943GE VIEWPOINTLLZSubstantially Equivalent
K050704MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONINGKPRSubstantially Equivalent
K050126GE LOGIQ TWINIYNSubstantially Equivalent
K043112GE 0.2T SIGNA PROFILE EXCITE MR SYSTEMLNHSubstantially Equivalent
K042257DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTIONKPSSubstantially Equivalent
K041922GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTORIZLSubstantially Equivalent
K041688GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04IYNSubstantially Equivalent
K041552GE VIVID 7 BT04IYNSubstantially Equivalent
K040444GE SIGNA 3.0T WITH EXCITE MR SYSTEMLNHSubstantially Equivalent
K033867GE BRAINWAVE OPTION(S) FOR MRI SYSTEMSLNHSubstantially Equivalent
K033504GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEMLNHSubstantially Equivalent
K033139GE MARLIN ULTRASOUNDIYNSubstantially Equivalent
K032477GE LOGIQ BOOKIYNSubstantially Equivalent
K032974GE LOGIQ 5 PRO OR EXPERTIYNSubstantially Equivalent
K033168GE 0.2T SIGNA PROFILE/I MR SYSTEMLNHSubstantially Equivalent
K032620GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEMIYNSubstantially Equivalent
K032182GE LOGIQ 7, MODEL 2354858IYNSubstantially Equivalent
K031663GE VIVID 7, MODEL FC0003XXIYNSubstantially Equivalent
K030874GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEMLNHSubstantially Equivalent
K030199GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEMKPSSubstantially Equivalent
K022872GE ROAD WARRIOR PET CT IMAGING SYSTEMKPSSubstantially Equivalent
K020789GE VIVID 3 EXPERT; GE VIVID 3 PROIYNSubstantially Equivalent
K020263LOGIQ 3IYNSubstantially Equivalent
K014206LOGIQBOOKIYOSubstantially Equivalent
K013381ADVANCED LUNG ANALYSIS-1JAKSubstantially Equivalent
K012568GE VISION NUCLEAR MEDICINE WORKSTATIONKPSSubstantially Equivalent
K012560GE LOGIQ A100 MP, MODEL 2272413IYOSubstantially Equivalent
K010329LOGIQ 500IYNSubstantially Equivalent
K010042CT PERFUSION 2JAKSubstantially Equivalent
K993069GE DIASONICS GATEWAY AND GATEWAY FXIYOSubstantially Equivalent
K991611GE LOGIQ 500IYOSubstantially Equivalent
K982004CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWSJAKSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain