Clearance Summary
MICRO-FOCUS 50 CABINET X-RAY received FDA 510(k) clearance under submission number K852634, sponsored by Micro-Focus Imaging., 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 1985-07-19.
- Submission: K852634
- Applicant / Sponsor: Micro-Focus Imaging., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1985-07-19
Classification & Regulation
This clearance is catalogued under FDA product code MWP and 21 CFR 892.1680, within the Radiology review panel as a Class II device.