Process 100 ST
FDA 510(k) K833846 · Cgr Medical Corp.
510(k) numberK833846
Submission
- Device name
- Process 100 ST
- Applicant
- Cgr Medical Corp.
Mchenry, IL, US - Received
- September 15, 1983
- Decision date
- December 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
More from Scott Imaging Intl., 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 |
| K841649 | Maximax - 4IZP · Traditional | 06/05/1984SE |
| K833223 | Sonel 3000AIYO · Traditional | 05/09/1984SE |
| K834306 | Phasix-High Frequency GeneratorITY · Traditional | 12/29/1983SE |
| K833941 | OrionIYE · Traditional | 12/29/1983SE |
| 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 Process 100 ST cleared by the FDA?
Process 100 ST (K833846) received a 510(k) decision of Substantially Equivalent on December 16, 1983, 92 days after the submission was received.
What is the product code of K833846?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.