Superix 120
FDA 510(k) K811197 · Tecnomed, Inc.
510(k) numberK811197
Submission
- Device name
- Superix 120
- Applicant
- Tecnomed, Inc.
Mchenry, IL, US - Received
- April 30, 1981
- Decision date
- June 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K820307 | Tecnomed Generator, Radiograph., 3 PhaseIZO · Traditional | 03/05/1982SE |
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| K820305 | Ralco Collimators, Manual RadiographicKPW · Traditional | 03/04/1982SE |
| K811196 | Allmec 90/15KXJ · Traditional | 06/09/1981SE |
| K811195 | ArgostatIYB · Traditional | 06/09/1981SE |
Questions and answers
When was Superix 120 cleared by the FDA?
Superix 120 (K811197) received a 510(k) decision of Substantially Equivalent on June 9, 1981, 40 days after the submission was received.
What is the product code of K811197?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.