Programmer, Changer, Film/Cassette, Radiographic
A radiographic film and cassette changer programmer is a device used to automatically advance and position film cassettes or image receptors in rapid sequence during serial angiographic or other dynamic radiographic examinations. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is IZP, regulated under 21 CFR 892.1870, within the Radiology medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- IZP
- Device Class
- FDA class 2
- Regulation Number
- 892.1870
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934944 | MPQ-42 | Dec 15, 1993 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K911888 | PHILIPS ANGIOPRO | Oct 15, 1991 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
| K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent | MALLINCKRODT GROUP, INC. |
| K904103 | SEP 90 | Nov 20, 1990 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K874451 | OMNIPLANE 200 FILM CHANGER SYSTEM | Feb 11, 1988 | Substantially Equivalent | MEDRAD, INC. |
| K854251 | THE CSE FILM CHANGER SYSTEM | Oct 28, 1985 | Substantially Equivalent | CHANGER SERVICE & ENGINEERING, INC. |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Aug 21, 1984 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Jun 05, 1984 | Substantially Equivalent | SYBRON CORP. |
| K841649 | MAXIMAX - 4 | Jun 05, 1984 | Substantially Equivalent | CGR MEDICAL CORP. |
| K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & | Feb 21, 1984 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
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.