Clearance Summary
iCAS-LV received FDA 510(k) clearance under submission number K231690, sponsored by Highrad , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-03-01.
- Submission: K231690
- Applicant / Sponsor: Highrad , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2024-03-01
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.