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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: DIRECTVIEW CR Mammography Cassette with EHR-M Screen/; DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen/; DIRECTVIEW CR Mammography Cassette with HR Screen/
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: Carestream Health, Inc
Registered Establishment Number: 1317307
Owner/Operator: CARESTREAM HEALTH, INC.
Owner/Operator Number: 9097221
Establishment Operations: Manufacturer
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