FDA-cleared K191262
aBSI
EXINI Diagnostics AB
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-08-05
Vendor
EXINI Diagnostics AB
3 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K211655
aPROMISE
EXINI Diagnostics AB
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-07-27
FDA-cleared K220590
aPROMISE X
EXINI Diagnostics AB
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-04-29