Clearance Summary
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004 received FDA 510(k) clearance under submission number K911267, sponsored by Tri W-G, 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 1991-04-03.
- Submission: K911267
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1991-04-03
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.