FDA-cleared K200873
HALO
NICo-Lab B.V.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-11-20
Vendor
NICo-Lab B.V.
3 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K211788
HALO
Nico.Lab B.V.
Image analysis/processing.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2021-07-08
FDA-cleared K231570
StrokeViewer Perfusion
NICo-Lab B.V.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-12-14