Cleared Traditional

K252353 - myray ProXIma X6 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252353 · Cefla S.C. · Radiology device
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Mar 2026
Decision
224d
Days
Class 2
Risk

K252353 is an FDA 510(k) clearance for the myray ProXIma X6. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on March 10, 2026 after a review of 224 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cefla S.C. devices

Submission Details

510(k) Number K252353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 107d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 129
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K252353.
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K251842 · Fussen Technology Co., Ltd. · Nov 2025
GT300
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K251642 · Yian Medical Technology (Haining) Co., Ltd. · Jun 2025