Clearance Summary
Vitrea CT Cardiac Analysis received FDA 510(k) clearance under submission number K222662, sponsored by Canon Medical Informatics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-10-14.
- Submission: K222662
- Applicant / Sponsor: Canon Medical Informatics, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2022-10-14
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.