Acuson SC2000 Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

SIEMENS MEDICAL SOLUTIONS, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Acuson Sc2000 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK142628
510k NumberK142628
Device Name:Acuson SC2000 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS, INC. 685 EAST MIDDLEFIELD RD. Mountain View,  CA  94043
ContactKevin Kong
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeOBJ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-09-16
Decision Date2014-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869003191 K142628 000
04056869003054 K142628 000

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