FUJI CR IMAGING PLATE
Device Facts
| Record ID | K862414 |
|---|---|
| Device Name | FUJI CR IMAGING PLATE |
| Applicant | Parexel Intl. Corp. |
| Product Code | EAM · Radiology |
| Decision Date | Feb 26, 1987 |
| 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.
