ACUSON

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 Acuson.

Pre-market Notification Details

Device IDK122825
510k NumberK122825
Device Name:ACUSON
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain View,  CA  94043
ContactShelly Pearce
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 Received2012-09-14
Decision Date2012-09-28

Trademark Results [ACUSON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACUSON
ACUSON
74626709 1974764 Live/Registered
SIEMENS MEDICAL SOLUTIONS USA,INC.
1995-01-27
ACUSON
ACUSON
73471651 1343987 Live/Registered
Acuson
1984-03-22

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