FDA 510(k)

Synapse PACS (7.6.0)

Número K: K261713 · 2026-06-18

RequerenteFUJIFILM Healthcare Americas Corporation

Data da decisão2026-06-18

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synapse PACS (7.6.0) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261713. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synapse PACS (7.6.0)?

Synapse PACS (7.6.0) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K261713.

When did Synapse PACS (7.6.0) receive FDA 510(k) clearance?

Synapse PACS (7.6.0) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261713.

Who is the listed applicant for Synapse PACS (7.6.0)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synapse PACS (7.6.0)?

The FDA product code for Synapse PACS (7.6.0) is QIH.

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Outros registros que listam FUJIFILM Healthcare Americas Corporation como candidato(a)

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Fonte oficial

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