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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Aspire HD; Aspire HD FFDM; FDR MS-1000; FDR-1000AWS v4.0; FDR-1000AWS v4.1
Classification Name: FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMMOGRAPHIC
Product Code: MUE
Device Class: 2
Regulation Number: 892.1715
Medical Specialty: Radiology
Registered Establishment Name: FUJIFILM CORPORATION
Registered Establishment Number: 3001722928
Owner/Operator: FUJIFILM CORPORATION
Owner/Operator Number: 8031568
Establishment Operations: Specification Developer
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