Synapse 3D Lung and Abdomen Analysis
FDA 510(k) K130542 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK130542
Submission
- Device name
- Synapse 3D Lung and Abdomen Analysis
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Stamford, CT, US - Received
- March 1, 2013
- Decision date
- June 14, 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 Synapse 3D Lung and Abdomen Analysis cleared by the FDA?
Synapse 3D Lung and Abdomen Analysis (K130542) received a 510(k) decision of Substantially Equivalent on June 14, 2013, 105 days after the submission was received.
What is the product code of K130542?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.