Clearance Summary
BriefCase-Quantification received FDA 510(k) clearance under submission number K241112, 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 2024-05-15.
- Submission: K241112
- Applicant / Sponsor: Aidoc Medical , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2024-05-15
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.