FDA 510(k)

攜帶式牙科X光設備（GT-1）

K 號：K254018 · 2026-02-19

申請人Guilin Refine Medical Instrument Co., Ltd.

決定日期2026-02-19

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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