Cleared Traditional

K252110 - Dental X-RAY Unit (AJX200) (FDA 510(k) Clearance)

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

K252110 · Guangzhou Ajax Medical Equipment Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
248d
Days
Class 2
Risk

K252110 is an FDA 510(k) clearance for the Dental X-RAY Unit (AJX200). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Guangzhou Ajax Medical Equipment Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 12, 2026 after a review of 248 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Guangzhou Ajax Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K252110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2025
Decision Date March 12, 2026
Days to Decision 248 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
141d slower than avg
Panel avg: 107d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 Consultant

Sgs-Cstc Standards Technical Services Co., Ltd.
Jett Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 188
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K252110.
NOMAD Pro 3
K253864 · Dental Imaging Technologies Corporation · Mar 2026
Portable Dental X-ray Device (GT-1)
K254018 · Guilin Refine Medical Instrument Co., Ltd. · Feb 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · Ningbo Runyes Medical Instrument Co., Ltd. · Feb 2026
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2025
Rextar Pro
K242185 · Raypia Co., Ltd. · Dec 2024
XERO-alpha
K242591 · DRTECH Corporation · Nov 2024