Eigen Dsa 2000
FDA 510(k) K063846 · Eigen
510(k) numberK063846
Submission
- Device name
- Eigen Dsa 2000
- Applicant
- Eigen
San Diego, CA, US - Received
- December 27, 2006
- Decision date
- January 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Eigen Dsa 2000 cleared by the FDA?
Eigen Dsa 2000 (K063846) received a 510(k) decision of Substantially Equivalent on January 26, 2007, 30 days after the submission was received.
What is the product code of K063846?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.