Medical Image Processing Unit, Model Ezsensor
FDA 510(k) K090526 · E-Woo Technology
510(k) numberK090526
Submission
- Device name
- Medical Image Processing Unit, Model Ezsensor
- Applicant
- E-Woo Technology
Houston, TX, US - Received
- February 26, 2009
- Decision date
- December 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Medical Image Processing Unit, Model Ezsensor cleared by the FDA?
Medical Image Processing Unit, Model Ezsensor (K090526) received a 510(k) decision of Substantially Equivalent on December 2, 2009, 279 days after the submission was received.
What is the product code of K090526?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.