ACUSON X300 ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, 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 X300 Ultrasound System.

Pre-market Notification Details

Device IDK072676
510k NumberK072676
Device Name:ACUSON X300 ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View,  CA  94039 -7393
ContactMartina Vogt
CorrespondentMartina Vogt
SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View,  CA  94039 -7393
Product CodeIYO  
Subsequent Product CodeDQO
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-21
Decision Date2007-12-18
Summary:summary

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