Myray- HYPERION X5
FDA 510(k) K152162 · Cefla S.C.
510(k) numberK152162
Submission
- Device name
- Myray- HYPERION X5
- Applicant
- Cefla S.C.
Imola (Bo), IT - Received
- August 3, 2015
- Decision date
- December 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Myray- HYPERION X5 cleared by the FDA?
Myray- HYPERION X5 (K152162) received a 510(k) decision of Substantially Equivalent on December 24, 2015, 143 days after the submission was received.
What is the product code of K152162?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.