FDA-cleared K190017
LiverMultiScan (LMSv3)
Perspectum Diagnostics Ltd
Image analysis/processing for Liver using MRI.
- Modality
- MRI
- Anatomy
- Liver
- Decision
- 2019-06-27
Use case
Oncology quantification radiology AI tools
A buyer-oriented shortlist for oncology quantification. Confirm exact intended use and local validation needs before any pilot or procurement decision.
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 K202170
LiverMultiScan
Perspectum LTD
Image analysis/processing for Liver using MRI.
- Modality
- MRI
- Anatomy
- Liver
- Decision
- 2020-10-02
FDA-cleared K203280
Hepatica v1 (Hepatica v1.0.0)
Perspectum Ltd.
Image analysis/processing for Liver using MRI.
- Modality
- MRI
- Anatomy
- Liver
- Decision
- 2021-01-12
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 K213776
LiverSmart
Resonance Health Analysis Services Pty Ltd
Image analysis/processing for Liver using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Liver
- Decision
- 2021-12-29
FDA-cleared K213960
LiverMultiScan v5 (LMSv5)
Perspectum
Image analysis/processing for Liver using MRI.
- Modality
- MRI
- Anatomy
- Liver
- Decision
- 2022-09-06
FDA-cleared K232045
MeVis Liver Suite
MeVis Medical Solutions AG
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2023-10-27
FDA-cleared K241543
DrAid™ for Liver Segmentation
VinBrain Joint Stock Company
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2024-12-06