ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite 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 Nx2 Diagnostic Ultrasound System, Acuson Nx2 Elite Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK172374
510k NumberK172374
Device Name:ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View,  CA  94043
ContactShelly Pearce
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-08-07
Decision Date2017-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869050775 K172374 000

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