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FDA 510(k)

Dental X-RAY Unit (AJX200)

K-Number: K252110 · 2026-03-12

Decision Date2026-03-12
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental X-RAY Unit (AJX200) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K252110. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental X-RAY Unit (AJX200)?

Dental X-RAY Unit (AJX200) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. The 510(k) number is K252110.

When did Dental X-RAY Unit (AJX200) receive FDA 510(k) clearance?

Dental X-RAY Unit (AJX200) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252110.

Who is the listed applicant for Dental X-RAY Unit (AJX200)?

The FDA 510(k) record lists Guangzhou Ajax Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental X-RAY Unit (AJX200)?

The FDA product code for Dental X-RAY Unit (AJX200) is EHD.

Other records listing Guangzhou Ajax Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.