ORWO X-RAY FILM
Device Facts
| Record ID | K920539 |
|---|---|
| Device Name | ORWO X-RAY FILM |
| Applicant | Burkhart Roentgen Intl., Inc. |
| Product Code | IWZ · Radiology |
| Decision Date | Jun 30, 1992 |
| 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.
