Clearance Summary
MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT received FDA 510(k) clearance under submission number K925956, sponsored by Nucletron-Oldelft 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 1993-11-19.
- Submission: K925956
- Applicant / Sponsor: Nucletron-Oldelft Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1993-11-19
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.