Clearance Summary
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 received FDA 510(k) clearance under submission number K231731, sponsored by Mcgovern Medical School. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-08-21.
- Submission: K231731
- Applicant / Sponsor: Mcgovern Medical School
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2023-08-21
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.