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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR

Manufacturer

Fujifilm Corporation

Date Cleared

2026-02-06

(81 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

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N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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