Arineta , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option, SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option, SpotLight/SpotLight Duo (with DLIR option)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arineta , Ltd. Radiology ✕
5 devices
Cleared
Apr 15, 2025
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Radiology
42d
Cleared
Jan 13, 2025
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
Radiology
258d
Cleared
Oct 13, 2023
SpotLight/SpotLight Duo (with DLIR option)
Radiology
245d
Cleared
Dec 02, 2022
CardioGraphe
Radiology
400d
Cleared
Aug 10, 2016
SpotLight CT
Radiology
117d