ESie Apps Suite

System, Image Processing, Radiological

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 Esie Apps Suite.

Pre-market Notification Details

Device IDK143254
510k NumberK143254
Device Name:ESie Apps Suite
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 685 EAST MIDDLEFIELD ROAD Mountain View,  CA  94043
ContactNancy Burke
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-11-13
Decision Date2014-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869063287 K143254 000
04056869003511 K143254 000
04056869235417 K143254 000

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