Tecnomed Generator, Radiograph., 3 Phase
FDA 510(k) K820307 · Tecnomed, Inc.
510(k) numberK820307
Submission
- Device name
- Tecnomed Generator, Radiograph., 3 Phase
- Applicant
- Tecnomed, Inc.
Mchenry, IL, US - Received
- February 4, 1982
- Decision date
- March 5, 1982
- 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 |
|---|---|---|
| K892226 | Tec 6340 90/15 Radiographic/Fluoroscopic TableIXR · Traditional | 04/26/1989SE |
| K854203 | Tec 2720 Mamex DC MagIZH · Traditional | 03/06/1986SE |
| K827126 | Technomed Generator, Radiographic, 3 Phase · Traditional | 03/05/1982SE |
| K827124 | Ralco Collimator, Automatic, Radiographic · Traditional | 03/05/1982SE |
| K820306 | Ralco Collimator, Automatic RadiographicKPW · Traditional | 03/05/1982SE |
| K827125 | Ralco Collimators, Manual, Radiographic · Traditional | 03/04/1982SE |
| K820305 | Ralco Collimators, Manual RadiographicKPW · Traditional | 03/04/1982SE |
| K811197 | Superix 120IZF · Traditional | 06/09/1981SE |
| K811196 | Allmec 90/15KXJ · Traditional | 06/09/1981SE |
| K811195 | ArgostatIYB · Traditional | 06/09/1981SE |
Questions and answers
When was Tecnomed Generator, Radiograph., 3 Phase cleared by the FDA?
Tecnomed Generator, Radiograph., 3 Phase (K820307) received a 510(k) decision of Substantially Equivalent on March 5, 1982, 29 days after the submission was received.
What is the product code of K820307?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.