Clearance Summary
HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR received FDA 510(k) clearance under submission number K851011, 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 1985-04-10.
- Submission: K851011
- Applicant / Sponsor: Hofmann X-Ray of America, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1985-04-10
Classification & Regulation
This clearance is catalogued under FDA product code IZO and 21 CFR 892.1700, within the Radiology review panel as a Class I device.