Clearance Summary
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART received FDA 510(k) clearance under submission number K002039, sponsored by Cti Pet Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-09-27.
- Submission: K002039
- Applicant / Sponsor: Cti Pet Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2000-09-27
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.