FDA-cleared K183204
Bone VCAR (BVCAR)
GE Medical Systems SCS
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2019-04-08
Vendor
GE Medical Systems SCS
12 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K193281
Hepatic VCAR
GE Medical Systems SCS
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2020-03-20
FDA-cleared K193289
FastStroke, CT Perfusion 4D
GE Medical Systems SCS
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-11-12
FDA-cleared K193306
PROView
GE Medical Systems SCS
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-11-17
FDA-cleared K210807
FlightPlan for Liver
GE Medical Systems SCS
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2021-10-22
FDA-cleared K213725
CardIQ Suite
GE Medical Systems SCS
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-03-11
FDA-cleared K223490
FlightPlan for Embolization
GE Medical Systems SCS
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2023-03-21
FDA-cleared K223424
Spine Auto Views
GE Medical Systems SCS
Image analysis/processing for Spine using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Spine
- Decision
- 2023-07-13
FDA-cleared K233731
CardIQ Suite
GE Medical Systems SCS
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-08-01
FDA-cleared K243446
3DXR
GE Medical Systems SCS
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-02-25
FDA-cleared K243651
VersaViewer
GE Medical Systems SCS
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-04-21
FDA-cleared K243672
CardIQ Suite
GE Medical Systems SCS
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-06-18