Clearance Summary
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 received FDA 510(k) clearance under submission number K051258, sponsored by Eastman Kodak Company. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-06-01.
- Submission: K051258
- Applicant / Sponsor: Eastman Kodak Company
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2005-06-01
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.