Siremobil Iso-C 3D
FDA 510(k) K032280 · Siemens AG
510(k) numberK032280
Submission
- Device name
- Siremobil Iso-C 3D
- Applicant
- Siemens AG
Mavern, PA, US - Received
- July 24, 2003
- Decision date
- September 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Siremobil Iso-C 3D cleared by the FDA?
Siremobil Iso-C 3D (K032280) received a 510(k) decision of Substantially Equivalent on September 10, 2003, 48 days after the submission was received.
What is the product code of K032280?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.