Device Recall Syngo.x Picture archiving and communication system 의 리콜

Device Model Numbers: 10863171, 10863172, 10863173  Serial Numbers: 401018 221363 221402 310364 222027 221225 130653 310395 310397 221110 130765 310310 450002 130848 130849 130692 310536 131037 221199 131200 130773 401005 130874 130706 401004 310363 400047 131011 130784 401062 310361 221192 221373 401070 222060 310544 310365 310388 310348 221280 401024 130772 310486 130628 130777 130998 131160 222025 221403 221388 221344 131127 222023 130716 221345 310472 130808 221198 130734 310396 102021 310460 131192 131132 310410 221235 130563 130916 130611 401026 221411 130770 310379 130984 221233 222008 400065 221204 131165 130837 130754 131057 130816 221390 221319 221296 131006 221109 130631 401007 221254 131131 130889 130803 400042 130711 130751 221425 130761 131012 100771 310418 130697 131013

Radiology Devices

2

No

Nationwide Distribution.

Syngo.x, Picture archiving and communication system || Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy