Medical Device Manufacturer · US , Waukesha , WI

Ge Healthcare - FDA 510(k) Cleared Devices

168 submissions · 168 cleared · Since 2004
168
Total
168
Cleared
0
Denied
123 devices
26-50 of 123
Cleared Sep 20, 2018
LOGIQ P9
K181783 · IYN
Radiology · 79d
Cleared May 14, 2018
Pristina Serena
K173576 · MUE
Radiology · 175d
Cleared May 04, 2018
Invenia ABUS Viewer
K180641 · LLZ
Radiology · 53d
Cleared Apr 17, 2018
NM/CT 850, NM/CT 860
K173816 · KPS
Radiology · 123d
Cleared Mar 29, 2018
Voluson P6 and Voluson P8
K180535 · IYN
Radiology · 29d
Cleared Mar 13, 2018
Voluson S8/ Voluson S10/ Voluson S10 Expert
K180374 · IYN
Radiology · 29d
Cleared Dec 20, 2017
LOGIQ E10
K173555 · IYN
Radiology · 33d
Cleared Oct 30, 2017
SenoBright HD
K172404 · MUE
Radiology · 82d
Cleared Sep 29, 2017
Voluson E6, Voluson E8, Voluson E10
K172342 · IYN
Radiology · 58d
Cleared Sep 01, 2017
Senographe Pristina
K163302 · MUE
Radiology · 283d
Cleared Apr 11, 2017
LOGIQ S8
K170445 · IYN
Radiology · 56d
Cleared Feb 10, 2017
LOGIQ P9 and LOGIQ P7
K163596 · IYN
Radiology · 51d
Cleared Nov 18, 2016
Discovery NM 750b Bopsy
K160933 · IYX
Radiology · 228d
Cleared Nov 03, 2016
Senographe Pristina
K162268 · MUE
Radiology · 83d
Cleared Oct 03, 2016
Voluson E6, Voluson E8, Voluson E10
K162269 · IYN
Radiology · 52d
Cleared Sep 01, 2016
SIGNA Voyager
K161567 · LNH
Radiology · 86d
Cleared Aug 01, 2016
Senolris
K160937 · LLZ
Radiology · 119d
Cleared May 05, 2016
LOGIQ P9 and LOGIQ P7
K161047 · IYN
Radiology · 22d
Cleared Apr 26, 2016
Voluson P6, Voluson P8
K160162 · IYN
Radiology · 90d
Cleared Mar 29, 2016
SIGNAPioneer
K160621 · LNH
Radiology · 25d
Cleared Mar 16, 2016
Xeleris 4.0 Processing and Review Workstation
K153355 · LLZ
Radiology · 117d
Cleared Feb 26, 2016
LOGIQ S7 Expert
K160182 · IYN
Radiology · 30d
Cleared Feb 25, 2016
Voluson S6, Voluson S8, Voluson S10
K160184 · IYN
Radiology · 29d
Cleared Jan 21, 2016
Discovery NM/CT 670 CZT
K153402 · KPS
Radiology · 58d
Cleared Nov 06, 2015
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
K152567 · IYN
Radiology · 58d

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