ACUSON IMAGE MANAGEMENT SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

ACUSON CORP.

The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson Image Management System.

Pre-market Notification Details

Device IDK921670
510k NumberK921670
Device Name:ACUSON IMAGE MANAGEMENT SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
ContactSheila W Pickering
CorrespondentSheila W Pickering
ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-08
Decision Date1992-06-25

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