Rayscan A-Expert
FDA 510(k) K122918 · Ray Co., Ltd.
510(k) numberK122918
Submission
- Device name
- Rayscan A-Expert
- Applicant
- Ray Co., Ltd.
Beverly Hills, CA, US - Received
- September 24, 2012
- Decision date
- March 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Rayscan A-Expert cleared by the FDA?
Rayscan A-Expert (K122918) received a 510(k) decision of Substantially Equivalent on March 15, 2013, 172 days after the submission was received.
What is the product code of K122918?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.