myray ProXIma X6

FDA 510(k) K252353 · Cefla S.C.

Substantially Equivalent

510(k) numberK252353

Submission

Device name
myray ProXIma X6
Applicant
Cefla S.C.
Imola (Bo), IT
Received
July 29, 2025
Decision date
March 10, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

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K220664NewTom 7GJAK · Traditional 05/06/2022SE
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Questions and answers

When was myray ProXIma X6 cleared by the FDA?

myray ProXIma X6 (K252353) received a 510(k) decision of Substantially Equivalent on March 10, 2026, 224 days after the submission was received.

What is the product code of K252353?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.