FDA 510(k)

便携式牙科X射线设备（GT-1）

K号: K254018 · 2026-02-19

申请人Guilin Refine Medical Instrument Co., Ltd.

决定日期2026-02-19

产品代码EHD

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决定实质等同

器械摘要

Portable Dental X-ray Device (GT-1) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K254018. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Portable Dental X-ray Device (GT-1)?

Portable Dental X-ray Device (GT-1) is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. The 510(k) number is K254018.

When did Portable Dental X-ray Device (GT-1) receive FDA 510(k) clearance?

Portable Dental X-ray Device (GT-1) received FDA 510(k) clearance on 2026-02-19, under 510(k) number K254018.

Who is the listed applicant for Portable Dental X-ray Device (GT-1)?

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

What is the FDA product code for Portable Dental X-ray Device (GT-1)?

The FDA product code for Portable Dental X-ray Device (GT-1) is EHD.

列明Guilin Refine Medical Instrument Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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