510(k) K854251
- Device
- The Cse Film Changer System
- Applicant
- CHANGER SERVICE & ENGINEERING, INC.
- 510(k) number
- K854251
- Product code
- IZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-10-28
- Date received
- 1985-10-22
- Regulation
- 892.1870
- Classification name
- Programmer, Changer, Film/Cassette, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEIF JOHANSSON
- Address
- 7832 Alabama St., Unit 7 Canoga Park CA US 91304 91304
FDA Registration Numbers#
- 3014150341
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IZP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934944 | MPQ-42 | Elema-Schonander, Inc. | 1993-12-15 |
| K911888 | PHILIPS ANGIOPRO | Philips Medical Systems North America, Inc. | 1991-10-15 |
| K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | Mallinckrodt Group, Inc. | 1990-12-13 |
| K904103 | SEP 90 | Elema-Schonander, Inc. | 1990-11-20 |
| K874451 | OMNIPLANE 200 FILM CHANGER SYSTEM | Medrad, Inc. | 1988-02-11 |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Elema-Schonander, Inc. | 1984-08-21 |
| K841649 | MAXIMAX - 4 | Cgr Medical Corp. | 1984-06-05 |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Sybron Corp. | 1984-06-05 |
| K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & | Elema-Schonander, Inc. | 1984-02-21 |