SEP 90
Device Facts
| Record ID | K904103 |
|---|---|
| Device Name | SEP 90 |
| Applicant | Elema-Schonander, Inc. |
| Product Code | IZP · Radiology |
| Decision Date | Nov 20, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1870 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.
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.
