KODAK EKTASIAN HG FILM (EHG-15)
Device Facts
| Record ID | K970154 |
|---|---|
| Device Name | KODAK EKTASIAN HG FILM (EHG-15) |
| Applicant | Eastman Kodak Company |
| Product Code | IWZ · Radiology |
| Decision Date | Apr 4, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1840 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.
