XEROX 128 CASSETTE CHANGER
Device Facts
| Record ID | K812024 |
|---|---|
| Device Name | XEROX 128 CASSETTE CHANGER |
| Applicant | Xerox Medical Systems |
| Product Code | KPX · Radiology |
| Decision Date | Aug 13, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1860 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.
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.
