ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO

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

Pre-market Notification Details

Device IDK132654
510k NumberK132654
Device Name:ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO 685 East Middlefield Road Mountain View,  CA  94043
ContactPatrick Lynch
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
Subsequent Product CodeOBJ
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-08-26
Decision Date2013-09-26
Summary:summary

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