Clearance Summary
SUPER SPEED POTTER-BUCKY (ESO5-110 & 220) received FDA 510(k) clearance under submission number K893690, sponsored by Hofmann X-Ray of America, 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 1989-07-20.
- Submission: K893690
- Applicant / Sponsor: Hofmann X-Ray of America, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1989-07-20
Classification & Regulation
This clearance is catalogued under FDA product code IXQ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.