21 CFR 892.1900 — Controller, Temperature, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1900
Identification
An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.
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 |
|---|---|---|---|---|
| EGT | Controller, Temperature, Radiographic | 2 | 0 | |
| EGW | Dryer, Film, Radiographic | 2 | 2 | |
| EGY | Processor, Radiographic-Film, Automatic, Dental | 2 | 9 | |
| IXW | Processor, Radiographic-Film, Automatic | 2 | 83 | |
| IXX | Processor, Cine Film | 2 | 6 |
Special Controls
EGT — Controller, Temperature, 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
EGW — Dryer, Film, 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
EGY — Processor, Radiographic-Film, Automatic, Dental
*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
IXW — Processor, Radiographic-Film, Automatic
*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
IXX — Processor, Cine Film
*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
