Clearance Summary
PET-SCOPE II MODEL DIS-1611 received FDA 510(k) clearance under submission number K801166, sponsored by Diagnostic Information, 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 1980-06-26.
- Submission: K801166
- Applicant / Sponsor: Diagnostic Information, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1980-06-26
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.