Acuson SC2000 Diagnostic Ultrasound System

System, Imaging, Pulsed Echo, Ultrasonic

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 Acuson Sc2000 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK211726
510k NumberK211726
Device Name:Acuson SC2000 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View,  CA  94043
ContactChristine Dunbar
CorrespondentChristine Dunbar
Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View,  CA  94043
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
Subsequent Product CodeLLZ
Subsequent Product CodeOBJ
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-04
Decision Date2021-11-05

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