Clearance Summary
ImagenSPECT 3.0 received FDA 510(k) clearance under submission number K201933, sponsored by Cardiovascular Imaging Technologies. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-08-11.
- Submission: K201933
- Applicant / Sponsor: Cardiovascular Imaging Technologies
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2020-08-11
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.