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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ImageChecker CAD; IMAGECHECKER M1000 SYSTEM
Classification Name: ANALYZER,MEDICAL IMAGE
Product Code: MYN
Device Class: 3
Registered Establishment Name: HOLOGIC, INC/R2
Registered Establishment Number: 2953690
Owner/Operator: HOLOGIC, INC.
Owner/Operator Number: 9007676
Establishment Operations: Specification Developer
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