Clearance Summary
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) received FDA 510(k) clearance under submission number K942264, sponsored by Eigen Video. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-07-20.
- Submission: K942264
- Applicant / Sponsor: Eigen Video
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1994-07-20
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.