BIOGRAPH 6

System, Tomography, Computed, Emission

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph 6.

Pre-market Notification Details

Device IDK060060
510k NumberK060060
Device Name:BIOGRAPH 6
ClassificationSystem, Tomography, Computed, Emission
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DRIVE Knoxville,  TN  37932
ContactM. Alaine Medio
CorrespondentM. Alaine Medio
SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DRIVE Knoxville,  TN  37932
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-09
Decision Date2006-02-03
Summary:summary

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