Acuson SC2000 Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, 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 IDK200585
510k NumberK200585
Device Name:Acuson SC2000 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, 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 CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeOBJ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-06
Decision Date2020-04-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869284583 K200585 000
04056869284521 K200585 000
04056869950747 K200585 000

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