FDA 510(k) Applications Submitted by GE Medical Systems Ultrasound and Primary care Diagnostics,
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220358 |
02/08/2022 |
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K231965 |
07/03/2023 |
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K231966 |
07/03/2023 |
LOGIQ E10 |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
| K232381 |
08/08/2023 |
LOGIQ Totus |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
| K163077 |
11/03/2016 |
LOGIQ E9, LOGIQ E9 XDClear 2.0 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K233692 |
11/17/2023 |
Voluson Signature 20, Voluson Signature 18 |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
| K214039 |
12/23/2021 |
LOGIQ P10, LOGIQ P9, LOGIQ P8 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K223407 |
11/09/2022 |
Versana Essential |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K251322 |
04/29/2025 |
Venue; Venue Go; Venue Fit; Venue Sprint |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
| K221147 |
04/20/2022 |
Vivid T8, Vivid T9 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K200119 |
01/21/2020 |
LOGIQ E10s |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K160277 |
02/02/2016 |
LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K210438 |
02/12/2021 |
Versana Premier |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K220446 |
02/16/2022 |
Versana Balance |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K220619 |
03/03/2022 |
Vivid S60N, Vivid S70N |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K180599 |
03/07/2018 |
Venue |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K220940 |
03/31/2022 |
EchoPAC Software Only, EchoPAC Plug-in |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K181685 |
06/26/2018 |
Vivid E80, Vivid E90, Vivid E95 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K181727 |
06/29/2018 |
Vivid iq |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K202035 |
07/23/2020 |
Vscan Air |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K202132 |
07/31/2020 |
Venue |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K202233 |
08/07/2020 |
Venue Go |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K182277 |
08/22/2018 |
Versana Premier |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K182450 |
09/07/2018 |
Vivid S60N, Vivid S70N |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K182750 |
09/28/2018 |
4D View |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K203137 |
10/20/2020 |
Venue Fit |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
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