Clearance Summary
PI808 MOBILE C-ARM IMAGE INTENSIFIER received FDA 510(k) clearance under submission number K820178, sponsored by Precise Optics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1982-03-04.
- Submission: K820178
- Applicant / Sponsor: Precise Optics
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1982-03-04
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.