FDR D-EVO III flat panel detector system
FDA 510(k) K192932 · Fujifilm Corporation
510(k) numberK192932
Submission
- Device name
- FDR D-EVO III flat panel detector system
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- October 17, 2019
- Decision date
- November 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was FDR D-EVO III flat panel detector system cleared by the FDA?
FDR D-EVO III flat panel detector system (K192932) received a 510(k) decision of Substantially Equivalent on November 12, 2019, 26 days after the submission was received.
What is the product code of K192932?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.