FDA-cleared K180599
Venue
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-05-02
Vendor
GE Medical Systems Ultrasound and Primary Care Diagnostics,
28 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K181685
Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2018-10-25
FDA-cleared K200497
Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-07-16
FDA-cleared K200851
Vivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-09
FDA-cleared K200852
EchoPAC Software Only, EchoPAC Plug-In
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-18
FDA-cleared K210438
Versana Premier
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-09-10
FDA-cleared K220446
Versana Balance
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-05-11
FDA-cleared K220358
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-06
FDA-cleared K220800
Venue Go
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-06-21
FDA-cleared K220619
Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-15
FDA-cleared K221147
Vivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-18
FDA-cleared K220940
EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-07-22
FDA-cleared K231965
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-10-30
FDA-cleared K231966
LOGIQ E10
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-11-07
FDA-cleared K232381
LOGIQ Totus
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2023-12-07
FDA-cleared K233692
Voluson Signature 20, Voluson Signature 18
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-03-07
FDA-cleared K242005
Versana Premier; Versana Premier Lotus; LOGIQ F
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-10-02
FDA-cleared K242168
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-12-20
FDA-cleared K243620
Vivid iq
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-11
FDA-cleared K243628
Vivid T9/Vivid T8
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-02-11
FDA-cleared K250087
Vscan Air
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-01
FDA-cleared K250543
Voluson Performance 16; Voluson Performance 18
GE Medical Systems Ultrasound and Primary care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-29
FDA-cleared K251169
Vivid Pioneer
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-10
FDA-cleared K251342
EchoPAC Software Only / EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-16
FDA-cleared K251322
Venue; Venue Go; Venue Fit; Venue Sprint
GE Medical Systems Ultrasound and Primary care Diagnostics,
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-07-25
FDA-cleared K251963
LOGIQ E10s
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-29
FDA-cleared K251985
LOGIQ E10
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-10-29
FDA-cleared K252328
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-11-24