21 CFR 892.1870 — Programmer, Changer, Film/Cassette, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1870
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 2 | 10 |
Special Controls
IZP — Programmer, Changer, Film/Cassette, Radiographic
*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.
eCFR
