Clearance Summary
BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY received FDA 510(k) clearance under submission number K924445, sponsored by Control-X, 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 1993-02-19.
- Submission: K924445
- Applicant / Sponsor: Control-X, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1880
- Decision date: 1993-02-19
Classification & Regulation
This clearance is catalogued under FDA product code IXY and 21 CFR 892.1880, within the Radiology review panel as a Class I device.