Cleared Special

K251438 - Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251438 · Guilin Woodpecker Medical Instrument Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
118d
Days
Class 2
Risk

K251438 is an FDA 510(k) clearance for the Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on September 4, 2025 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Guilin Woodpecker Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K251438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2025
Decision Date September 04, 2025
Days to Decision 118 days
Submission Type Special
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
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

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

Irc
Charles Mack

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 K251438.
NOMAD Pro 3
K253864 · Dental Imaging Technologies Corporation · Mar 2026
Dental X-RAY Unit (AJX200)
K252110 · Guangzhou Ajax Medical Equipment Co., Ltd. · 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
Rextar Pro
K242185 · Raypia Co., Ltd. · Dec 2024
XERO-alpha
K242591 · DRTECH Corporation · Nov 2024