Arineta Ltd.

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Arineta Ltd. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2025-04-15	K250650	SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option	Arineta Ltd.	Radiology
2025-01-13	K241200	SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option	Arineta Ltd.	Radiology
2023-10-13	K230370	SpotLight/SpotLight Duo (with DLIR option)	Arineta Ltd.	Radiology

All companies