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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Biograph 16 TP-3R; Biograph 16 TP-4R; Biograph 16 TruePoint; Biograph 16 TruePoint w/TrueV; Biograph 40 TP-3R; Biograph 40 TP-4R; Biograph 40 TruePoint; Biograph 40 TruePoint w/TrueV; Biograph 6 TP-3R; Biograph 6 TP-4R; Biograph 6 TruePoint; Biograph 6 TruePoint w/TrueV; Biograph 64 TP-3R; Biograph 64 TP-4R; Biograph 64 TruePoint; Biograph 64 TruePoint w/TrueV; Biograph TruePoint
Classification Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Product Code: JAK
Device Class: 2
Regulation Number: 892.1750
Medical Specialty: Radiology
Registered Establishment Name: SIEMENS MEDICAL SOLUTIONS USA, INC.
Registered Establishment Number: 1034973
Premarket Submission Number: K141971
Owner/Operator: SIEMENS MEDICAL SOLUTIONS USA, INC.
Owner/Operator Number: 9002915
Establishment Operations: Specification Developer
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