MODIFICATION TO ACUSON ANTARES 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 Modification To Acuson Antares Ultrasound System.

Pre-market Notification Details

Device IDK063138
510k NumberK063138
Device Name:MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View,  CA  94039 -7393
ContactSheila W Pickering Ph.d.
CorrespondentSheila W Pickering Ph.d.
SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View,  CA  94039 -7393
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-16
Decision Date2006-11-22
Summary:summary

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