FDA 510(k)

Hand-held Dental X-ray System (HyperLight-M)

Número K: K260795 · 2026-09-14

RequerenteChangzhou Sifary Medical Technology Co., Ltd.

Data da decisão2026-09-14

Código do produtoEHD

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hand-held Dental X-ray System (HyperLight-M) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-14 under 510(k) number K260795. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hand-held Dental X-ray System (HyperLight-M)?

Hand-held Dental X-ray System (HyperLight-M) is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K260795.

When did Hand-held Dental X-ray System (HyperLight-M) receive FDA 510(k) clearance?

Hand-held Dental X-ray System (HyperLight-M) received FDA 510(k) clearance on 2026-09-14, under 510(k) number K260795.

Who is the listed applicant for Hand-held Dental X-ray System (HyperLight-M)?

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

What is the FDA product code for Hand-held Dental X-ray System (HyperLight-M)?

The FDA product code for Hand-held Dental X-ray System (HyperLight-M) is EHD.

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Outros registros que listam Changzhou Sifary Medical Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: EHD)

K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies Corporation K252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument Co., Ltd.

Fonte oficial

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