MCI OPTONIX ECONOMY CASSETTE
Device Facts
| Record ID | K953444 |
|---|---|
| Device Name | MCI OPTONIX ECONOMY CASSETTE |
| Applicant | Mci Optonix, Inc. |
| Product Code | IXA · Radiology |
| Decision Date | Aug 2, 1995 |
| 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.
