Polytron Digital Imaging System
FDA 510(k) K920705 · Siemens Medical Solutions USA, Inc.
510(k) numberK920705
Submission
- Device name
- Polytron Digital Imaging System
- Applicant
- Siemens Medical Solutions USA, Inc.
Iselin, NJ, US - Received
- February 18, 1992
- Decision date
- April 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Polytron Digital Imaging System cleared by the FDA?
Polytron Digital Imaging System (K920705) received a 510(k) decision of Substantially Equivalent on April 27, 1992, 69 days after the submission was received.
What is the product code of K920705?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.