Clearance Summary
PXI URCD received FDA 510(k) clearance under submission number K913435, sponsored by Brotherston/Pxi. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-11-05.
- Submission: K913435
- Applicant / Sponsor: Brotherston/Pxi
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1992-11-05
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.