Maximax - 4
FDA 510(k) K841649 · Cgr Medical Corp.
510(k) numberK841649
Submission
- Device name
- Maximax - 4
- Applicant
- Cgr Medical Corp.
Walker, MI, US - Received
- April 20, 1984
- Decision date
- June 5, 1984
- 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 |
| K854251 | The Cse Film Changer SystemIZP · Traditional | Changer Service & Engineering, Inc. | 10/28/1985SE |
| 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 |
| K840389 | Sep Programmer Sep-M/Single-Plane &IZP · Traditional | Elema-Schonander, Inc. | 02/21/1984SE |
More from Elema-Schonander, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843926 | Prestilix 1690IXR · Traditional | 12/17/1984SE |
| K843235 | StenoscopJAA · Traditional | 11/08/1984SE |
| K843985 | Suspension 7 · Traditional | 11/05/1984SE |
| K833223 | Sonel 3000AIYO · Traditional | 05/09/1984SE |
| K834306 | Phasix-High Frequency GeneratorITY · Traditional | 12/29/1983SE |
| K833941 | OrionIYE · Traditional | 12/29/1983SE |
| K833846 | Process 100 STIZO · Traditional | 12/16/1983SE |
| K837465 | Alcyon Rotational Cobalt Therapy · Traditional | 06/28/1983SE |
| K837412 | Saturne I Linear Accelerator · Traditional | 06/28/1983SE |
| K837336 | Verasun Radiation Therapy Simulation System · Traditional | 04/29/1983SE |
Questions and answers
When was Maximax - 4 cleared by the FDA?
Maximax - 4 (K841649) received a 510(k) decision of Substantially Equivalent on June 5, 1984, 46 days after the submission was received.
What is the product code of K841649?
The FDA product code is IZP – Programmer, Changer, Film/Cassette, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1870.