Clearance Summary
SELECTOR MD (50KW AND 80 KW) received FDA 510(k) clearance under submission number K910650, sponsored by Hofmann-Nagel Medical 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 1991-06-06.
- Submission: K910650
- Applicant / Sponsor: Hofmann-Nagel Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1991-06-06
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.