Clearance Summary
B-4 FOUR-WAY RADIOGRAPHIC TABLE received FDA 510(k) clearance under submission number K924444, 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 1993-02-05.
- Submission: K924444
- Applicant / Sponsor: Control-X, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1993-02-05
Classification & Regulation
This clearance is catalogued under FDA product code IZZ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.