EGW · Dryer, Film, Radiographic
Radiology · 21 CFR 892.1900 · Class 2
Overview
| Product Code | EGW |
|---|---|
| Device Name | Dryer, Film, Radiographic |
| Regulation | 21 CFR 892.1900 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K902531 | EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL | G-C Intl. Corp. | Jul 13, 1990 | SESE |
| K760846 | PAKOSTAT II | Pako Corp. | Jan 7, 1977 | SESE |
Top Applicants
- Pako Corp. — 1 clearance
- G-C Intl. Corp. — 1 clearance
