The Cse Film Changer System
FDA 510(k) K854251 · Changer Service & Engineering, Inc.
510(k) numberK854251
Submission
- Device name
- The Cse Film Changer System
- Applicant
- Changer Service & Engineering, Inc.
Canoga Park, CA, US - Received
- October 22, 1985
- Decision date
- October 28, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934944 | MPQ-42IZP · Traditional | Elema-Schonander, Inc. | 12/15/1993SE |
| K911888 | Philips AngioproIZP · Traditional | Philips Medical Systems North America, Inc. | 10/15/1991SE |
| K904144 | Pulmovision Chest Radiography X-Ray SystemIZP · Traditional | Mallinckrodt Group, Inc. | 12/13/1990SE |
| K904103 | Sep 90IZP · Traditional | Elema-Schonander, Inc. | 11/20/1990SE |
| K874451 | Omniplane 200 Film Changer SystemIZP · Traditional | Medrad, Inc. | 02/11/1988SE |
| K842903 | Sep Programmer for Puck U & Ud FilmchangIZP · Traditional | Elema-Schonander, Inc. | 08/21/1984SE |
| K841732 | Liebel-Flarsheim Afc 1000 X-Ray FilmIZP · Traditional | Sybron Corp. | 06/05/1984SE |
| K841649 | Maximax - 4IZP · Traditional | Cgr Medical Corp. | 06/05/1984SE |
| K840389 | Sep Programmer Sep-M/Single-Plane &IZP · Traditional | Elema-Schonander, Inc. | 02/21/1984SE |
Questions and answers
When was The Cse Film Changer System cleared by the FDA?
The Cse Film Changer System (K854251) received a 510(k) decision of Substantially Equivalent on October 28, 1985, 6 days after the submission was received.
What is the product code of K854251?
The FDA product code is IZP – Programmer, Changer, Film/Cassette, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1870.