KYOKKO UM SERIES INTENSIFYING SCREEN
Device Facts
| Record ID | K942399 |
|---|---|
| Device Name | KYOKKO UM SERIES INTENSIFYING SCREEN |
| Applicant | Fujifilm Medical System U.S.A., Inc. |
| Product Code | EAM · Radiology |
| Decision Date | Jun 10, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1960 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.
