ACUSON X800 Diagnostic 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 Acuson X800 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK180067
510k NumberK180067
Device Name:ACUSON X800 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View,  CA  94043
ContactSulgue Choi
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-01-09
Decision Date2018-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869173566 K180067 000
04056869284576 K180067 000
04056869051970 K180067 000
04056869051987 K180067 000
04056869051994 K180067 000
04056869052014 K180067 000
04056869052021 K180067 000
04056869052045 K180067 000
04056869052069 K180067 000
04056869061870 K180067 000
04056869062013 K180067 000
04056869284569 K180067 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.