Clearance Summary
TOP-X 650HF RADIOGRAPHIC X-RAY received FDA 510(k) clearance under submission number K920347, 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 1993-05-17.
- Submission: K920347
- Applicant / Sponsor: Control-X, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1993-05-17
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.