ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems

System, Imaging, Pulsed Doppler, Ultrasonic

Siemens Medical Solutions USA, Inc. Ultrasound Group

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. Ultrasound Group with the FDA for Acuson S1000/s2000/s3000 Diagnostic Ultrasound Systems.

Pre-market Notification Details

Device IDK163635
510k NumberK163635
Device Name:ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Siemens Medical Solutions USA, Inc. Ultrasound Group 685 East Middlefield Road Mountain View,  CA  94043
ContactSulgue Choi
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 Received2016-12-22
Decision Date2017-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869284538 K163635 000
04056869950754 K163635 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.