ProFuse CAD
FDA 510(k) K173744 · Eigen
510(k) numberK173744
Submission
- Device name
- ProFuse CAD
- Applicant
- Eigen
Grass Valley, CA, US - Received
- December 7, 2017
- Decision date
- November 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ProFuse CAD cleared by the FDA?
ProFuse CAD (K173744) received a 510(k) decision of Substantially Equivalent on November 21, 2018, 349 days after the submission was received.
What is the product code of K173744?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.