Polyphos 500
FDA 510(k) K812616 · Siemens Corp.
510(k) numberK812616
Submission
- Device name
- Polyphos 500
- Applicant
- Siemens Corp.
Walker, MI, US - Received
- September 15, 1981
- Decision date
- October 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
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| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
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| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
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Questions and answers
When was Polyphos 500 cleared by the FDA?
Polyphos 500 (K812616) received a 510(k) decision of Substantially Equivalent on October 13, 1981, 28 days after the submission was received.
What is the product code of K812616?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.