U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Software anomaly related to recist1.1 target lesion evaluation criteria in findings workflow module within the aquarius intuition client viewer.
조치
Medical Device Correction letters were sent to all affected users on January 21, 2015 by both e-mail and physical mail - certified mail for us customers and FEDEX for international customers.
Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.
제품 설명
Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: || Picture Archiving and Communications System; || Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. || A fully-configured iNtuition system is capable of various image processing and || visualization functions, including basic features and advanced post processing || modules. The system can be configured as a server with some, all, or none of its || optional features disabled. || The intended use of the device is to provide solutions to various medical || image-analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant.