The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. US: Nationwide Distribution in the states of CA, FLĪnd countries of : France, United Kingdom, Germany, Australiaġ A record in this database is created when a firm initiates a correction or removal action. Postal Address: Simpleware Product Group, Synopsys Northern Europe Ltd., Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, UK Complete the customer reply form by Jand submit to Helpline +44(0)1392 428752 This action can be completed by using the ͍ICOM tags tool in the General section of the Home tab.Ĥ. align or flip) through the GUI or scripting. " Or applying any image rotation transforms (e.g. " Using the Register datasets tool through the GUI or scripting. If this is not immediately possible, the user should always remove all DICOM tags before: The user should also uninstall and/or delete previous installers.ģ.
#SCANIP SIMPLEWARE UPGRADE#
The user should stop using Simpleware ScanIP Medical R-2021.03 and earlier versions and immediately upgrade to the latest version (S-2021.06a/S-2021.06) of the software on SolvNetPlus.Ģ. In addition to informing consignees about the recall, the firm request consignees take the following actions:ġ. Synopsys sent a "Urgent Field Safety Notice" on Jvia E-Mail. Software Manufacturing/Software Deployment This could result in operator misunderstanding and errors during resampling or re-alignment of image data Simpleware Product Group, SYNOPSYS NORTHERN EUROPEĪ issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. Simpleware ScanIP software.ğor transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.Īffected version/UDI Simpleware ScanIP 7.0: Created before UDI-DI system (released December 2nd, 2014), Simpleware ScanIP 2016.09: 00863520000307, Simpleware ScanIP M-2017.06: 00863520000314, Simpleware ScanIP N-2018.03: 00863520000321
#SCANIP SIMPLEWARE CODE#
Examples include: the incorporation of mobile phone designs into MRI head models to explore EM exposure (or comfort and fit with the ear) the exploration of the effect of stent or cannula insertion on blood flow and the virtual modelling of dental surgery.System, image processing, radiological - Product Code LLZ The functionality provided opens the door to modelling a wide range of problems in medicine and dentistry as well as in consumer product design.
+ScanCAD provides a unique approach to merging CAD and image data whilst preserving the features and fidelity of the scanned image. Constrained motion positioning along user-defined vectors.
Real-time interactive or keyboard input for positioning.'On the fly' repair of non-watertight CAD models.Direct import of most common CAD formats into 3D image.User-customisable graphical interface with 2D/3D views.sensitivity of stress field to implant alignment, use of different reaming tools, etc.) can be tested straightforwardly. Post-operative performance can be simulated using the combined models and multiple scenarios (e.g. The module can be used, for example, to obtain patient specific models by positioning CAD models of different implants within a pre-operative scan. The +ScanCAD module bolts onto ScanIP and provides a range of tools for the integration of CAD models into the 3D image.
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