21 CFR 892.1860 — Changer, Radiographic Film/Cassette
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1860
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.
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 |
|---|---|---|---|---|
| KPX | Changer, Radiographic Film/Cassette | 2 | 26 |
Special Controls
KPX — Changer, Radiographic Film/Cassette
*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
