FDA-cleared K182419
Centricity Universal Viewer
GE Healthcare
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2018-12-14
Vendor
GE Healthcare
7 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K201103
Xeleris V Processing and Review Systems
GE Healthcare
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-09-25
FDA-cleared K213642
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
GE Healthcare
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-01-13
FDA-cleared K213689
Voluson P6, Voluson P8
GE Healthcare
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-02-17
FDA-cleared K221680
Xeleris V Processing and Review System
GE Healthcare
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-03-01
FDA-cleared K223212
Precision DL
GE Healthcare
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-04-27
FDA-cleared K242925
MR Contour DL
GE HealthCare
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-04-01