Clearance Summary
FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG received FDA 510(k) clearance under submission number K850198, sponsored by Summit Industries, 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 1985-05-14.
- Submission: K850198
- Applicant / Sponsor: Summit Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1770
- Decision date: 1985-05-14
Classification & Regulation
This clearance is catalogued under FDA product code IYB and 21 CFR 892.1770, within the Radiology review panel as a Class I device.