Clearance Summary
MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR received FDA 510(k) clearance under submission number K860025, sponsored by Medicor USA , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1986-05-07.
- Submission: K860025
- Applicant / Sponsor: Medicor USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1986-05-07
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.