Clearance Summary
KODAK EKTASIAN HG FILM (EHG-15) received FDA 510(k) clearance under submission number K970154, sponsored by Eastman Kodak Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-04-04.
- Submission: K970154
- Applicant / Sponsor: Eastman Kodak Company
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1840
- Decision date: 1997-04-04
Classification & Regulation
This clearance is catalogued under FDA product code IWZ and 21 CFR 892.1840, within the Radiology review panel as a Class I device.