FDA 510(k)

Portable Dental X-ray Device (GT-1)

K-번호: K254018 · 2026-02-19

신청자Guilin Refine Medical Instrument Co., Ltd.

결정일2026-02-19

제품 코드EHD

자문 위원회의료 장비 규제 텍스트 번역 DE [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료 장비로, 510(k) 신청을 통해 승인을 받았습니다. 이 제품은 PMA(Premarket Approval)를 받지 않았으며, NCT(National Clinical Trial) 등록 번호는 [NCT 번호]입니다. PMID(Publication Medical Identifier)은 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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