Cleared Traditional

myray ProXIma X6

K252353 · Cefla S.C. · Radiology

Mar 2026

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K252353 is an FDA 510(k) clearance for the myray ProXIma X6, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on March 10, 2026, 224 days after receiving the submission on July 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K252353 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2025
Decision Date	March 10, 2026
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OAS — X-ray, Tomography, Computed, Dental
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1750
Definition	Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.