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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CR HD5.0 AEC Cassette; CR HD5.0 AEC Detector; CR HD5.0 FLFS Cassette; CR HD5.0 FLFS Detector; CR HD5.0 General Detector; CR HD5.0 General SR Detector; CR HM5.0 Mammo Cassette; CR HM5.0 Mammo Detector; CR MD4.0R FLFS Cassette; CR MD4.0R FLFS Set; CR MD4.0R General Cassette; CR MD4.0R General Plate; CR MD4.0R General Set; CR MD4.0R General SR Cassette; CR MD4.0R General SR Plate; CR MD4.0R General SR Set; CR MD5.0 General Cassette; DX-M; NX
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: AGFA HEALTHCARE GMBH
Registered Establishment Number: 9613152
Owner/Operator: AGFA HEALTHCARE N.V.
Owner/Operator Number: 9011611
Establishment Operations: Manufacturer
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