Eva Select Digital Dental Imaging System
FDA 510(k) K123419 · Afp Imaging Corp.
510(k) numberK123419
Submission
- Device name
- Eva Select Digital Dental Imaging System
- Applicant
- Afp Imaging Corp.
Naples, FL, US - Received
- November 6, 2012
- Decision date
- December 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Eva Select Digital Dental Imaging System cleared by the FDA?
Eva Select Digital Dental Imaging System (K123419) received a 510(k) decision of Substantially Equivalent on December 27, 2012, 51 days after the submission was received.
What is the product code of K123419?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.