Somatom Confidence ® RT Pro

System, X-ray, Tomography, Computed

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 Somatom Confidence ® Rt Pro.

Pre-market Notification Details

Device IDK162302
510k NumberK162302
Device Name:Somatom Confidence ® RT Pro
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD., MAIL CODE 65-1A Malvern,  PA  19355
ContactKimberly Mangum
CorrespondentKimberly Mangum
SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD., MAIL CODE 65-1A Malvern,  PA  19355
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-17
Decision Date2016-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869011011 K162302 000

Trademark Results [Somatom Confidence]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOMATOM CONFIDENCE
SOMATOM CONFIDENCE
79190713 5268323 Live/Registered
Siemens Healthcare GmbH
2016-07-01

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