FDA-cleared K230370
SpotLight/SpotLight Duo (with DLIR option)
Arineta Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-10-13
Vendor
Arineta Ltd.
3 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K241200
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-01-13
FDA-cleared K250650
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-04-15