ClariPlatform
ClariPI Inc. · Model ClariSuite View · UDI-DI 08800046800167
Description
ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment. The system facilitates the networking, filtering, routing, and optional de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. Additionally the system allows users to interact with the AI analysis results including confirming, rejecting, and selecting other category than provided by AI. While ClariPlatform (Ver.1.0) operates as a cloud-based system, ClariPlatform (Ver. ClariSuite View) is specifically designed for on-premise deployment, ensuring compliance with institutional security policies, regulatory requirements, and data privacy concerns. ClariPlatform (Ver. ClariSuite View) is deployed within anorganization’s internal infrastructure, allowing healthcare providers to maintain full control over medical imaging data while leveraging advanced AI-assisted visualization tools. Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-09-11 | Skytron, Div. The KMW Group, Inc | VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display |
| 2020-03-10 | Skytron, Div. The KMW Group, Inc | Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image wh |
| 2015-12-04 | CompView Medical, LLC | The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release |
| 2015-05-06 | Siemens Medical Solutions USA, Inc | A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching |
| 2014-06-25 | Karl Storz Endoscopy | KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessat |
| 2012-04-19 | Ge Healthcare It | GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to |
| 2009-12-11 | Stryker Endoscopy | Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start fr |
| 2008-12-12 | GE Healthcare Integrated IT Solutions | Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an o |
| 2007-12-11 | AGFA Corp. | Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by |
| 2007-05-02 | Siemens Medical Solutions USA, Inc | System could crash and result in data loss. |
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