Clearance Summary
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM received FDA 510(k) clearance under submission number K012546, sponsored by Sedecal USA, 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 2001-11-02.
- Submission: K012546
- Applicant / Sponsor: Sedecal USA, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2001-11-02
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.