IXX · Processor, Cine Film
Radiology · 21 CFR 892.1900 · Class 2
Overview
| Product Code | IXX |
|---|---|
| Device Name | Processor, Cine Film |
| 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963334 | JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 | Jamieson Film Co. | Sep 11, 1996 | SESE |
| K915365 | AP-6CR CINERADIOGRAPHIC FILM PROCESSOR | The Allen Products Co. | Aug 27, 1992 | SESE |
| K913241 | JAMIESON JT-CRP CINE FILM PROCESSOR | Jamieson Film Co. | Sep 24, 1991 | SESE |
| K861928 | STERILE O. R. TOWEL | Anago, Inc. | Jun 9, 1986 | SESE |
| K850421 | CINE RADIOGRAPHIC FILM PROCESSOR M-45CR | The Allen Products Co. | Mar 22, 1985 | SESE |
| K841431 | RADIOGRAPHIC FILM PROCESSOR M-30CR & | The Allen Products Co. | Jul 6, 1984 | SESE |
Top Applicants
- The Allen Products Co. — 3 clearances
- Jamieson Film Co. — 2 clearances
- Anago, Inc. — 1 clearance
