FUJIFILM EC-B SERIES CASETTE
Device Facts
| Record ID | K932565 |
|---|---|
| Device Name | FUJIFILM EC-B SERIES CASETTE |
| Applicant | Fujifilm Medical System U.S.A., Inc. |
| Product Code | IXA · Radiology |
| Decision Date | Jul 26, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1850 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
