ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System

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 Ultrasuond System.

Pre-market Notification Details

Device IDK152369
510k NumberK152369
Device Name:ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP 685 East Middlefield Road Mountain View,  CA  94043
ContactNancy Burke
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 Received2015-08-21
Decision Date2015-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869003177 K152369 000
04056869002873 K152369 000
04056869002798 K152369 000
04056869002781 K152369 000
04056869002750 K152369 000

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