Clearance Summary
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS received FDA 510(k) clearance under submission number K030690, sponsored by Codonics, 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 2003-04-30.
- Submission: K030690
- Applicant / Sponsor: Codonics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 2003-04-30
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.