Clearance Summary
ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM received FDA 510(k) clearance under submission number K925705, sponsored by Denar Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-12-28.
- Submission: K925705
- Applicant / Sponsor: Denar Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1920
- Decision date: 1992-12-28
Classification & Regulation
This clearance is catalogued under FDA product code IWY and 21 CFR 892.1920, within the Radiology review panel as a Class I device.