Clearance Summary
UXM MODEL 8188 received FDA 510(k) clearance under submission number K840678, sponsored by Universal X-Ray. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1984-03-16.
- Submission: K840678
- Applicant / Sponsor: Universal X-Ray
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1984-03-16
Classification & Regulation
This clearance is catalogued under FDA product code IZX and 21 CFR 892.1610, within the Radiology review panel as a Class II device.