Clearance Summary
SCOPIX VIDEO IMAGER received FDA 510(k) clearance under submission number K882096, sponsored by Agfa-Gevaert, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1988-08-09.
- Submission: K882096
- Applicant / Sponsor: Agfa-Gevaert, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 1988-08-09
Classification & Regulation
This clearance is catalogued under FDA product code LMC and 21 CFR 892.2040, within the Radiology review panel as a Class II device.