Clearance Summary
BriefCase-Triage received FDA 510(k) clearance under submission number K243548, sponsored by Aidoc Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-12-11.
- Submission: K243548
- Applicant / Sponsor: Aidoc Medical , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2080
- Decision date: 2024-12-11
Classification & Regulation
This clearance is catalogued under FDA product code QFM and 21 CFR 892.2080, within the Radiology review panel as a Class II device.