Clearance Summary
DFI-1000 AND DVS-475 IMAGING DEVICES received FDA 510(k) clearance under submission number K951261, sponsored by Nical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-03-15.
- Submission: K951261
- Applicant / Sponsor: Nical
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1996-03-15
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.