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 IDK181098
510k NumberK181098
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
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 Received2018-04-26
Decision Date2018-05-31
Summary:summary

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