Mammography Viewer SMV658
FDA 510(k) K132188 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK132188
Submission
- Device name
- Mammography Viewer SMV658
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Stamford, CT, US - Received
- July 15, 2013
- Decision date
- October 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mammography Viewer SMV658 cleared by the FDA?
Mammography Viewer SMV658 (K132188) received a 510(k) decision of Substantially Equivalent on October 25, 2013, 102 days after the submission was received.
What is the product code of K132188?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.