Clearance Summary
ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 received FDA 510(k) clearance under submission number K023768, sponsored by Cti Pet Systems, 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 2002-11-25.
- Submission: K023768
- Applicant / Sponsor: Cti Pet Systems, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2002-11-25
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.