Processor, Cine Film
A cine film processor is an automatic processing device specifically designed to develop cine radiographic film, such as that used in cardiac catheterization and angiography procedures, where images are captured at high frame rates on motion picture film. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXX, regulated under 21 CFR 892.1900, within the Radiology medical specialty.
Basic Information
- Product Code
- IXX
- Device Class
- FDA class 2
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963334 | JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 | Sep 11, 1996 | Substantially Equivalent | Jamieson Film Co. |
| K915365 | AP-6CR CINERADIOGRAPHIC FILM PROCESSOR | Aug 27, 1992 | Substantially Equivalent | The Allen Products Co. |
| K913241 | JAMIESON JT-CRP CINE FILM PROCESSOR | Sep 24, 1991 | Substantially Equivalent | Jamieson Film Co. |
| K861928 | STERILE O. R. TOWEL | Jun 09, 1986 | Substantially Equivalent | Anago, Inc. |
| K850421 | CINE RADIOGRAPHIC FILM PROCESSOR M-45CR | Mar 22, 1985 | Substantially Equivalent | The Allen Products Co. |
| K841431 | RADIOGRAPHIC FILM PROCESSOR M-30CR & | Jul 06, 1984 | Substantially Equivalent | The Allen Products Co. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.