Clearance Summary
MICROSELECTRON V3, MODEL 106.990 received FDA 510(k) clearance under submission number K061354, sponsored by Nucletron Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-08-17.
- Submission: K061354
- Applicant / Sponsor: Nucletron Corporation
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2006-08-17
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.