Clearance Summary
Autoplaque received FDA 510(k) clearance under submission number K212758, sponsored by Cedars-Sinai Medical Center: Aim. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-05-19.
- Submission: K212758
- Applicant / Sponsor: Cedars-Sinai Medical Center: Aim
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2023-05-19
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.