Simpleware ScanIP software receives FDA 510(k) market clearance

Simpleware ScanIP software receives FDA 510(k) market clearance

April 23, 2015

UK-based Simpleware’s 3D image processing software ScanIP has received 510(k) marketing clearance from the U.S. Food and Drug Administration.
ScanIP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or an MRI scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.*
ScanIP provides a core image processing interface with additional modules available for users, including +CAD (integration of CAD drawings with image data), +FE (export of computational models from image data), and +NURBS (export of segmented image data as IGES files to CAD software).
Simpleware managing director Dr Philippe Young commented: “we are very excited about this FDA 510(k) market clearance, which will be a great help to us in widening awareness and use of our software in the U.S. medical market and worldwide. At Simpleware we’re committed to producing very high-quality software solutions to meet the demands of working with complex 3D images, and this demonstrates our ambition for the software.”
As well as medical applications, ScanIP is used by researchers in other industries such as the Materials Sciences, Oil and Gas and Industrial Reverse Engineering and Non-Destructive Testing to create high-quality 3D models from imaging data.
* ScanIP is not intended for use for mammography imaging.
About Simpleware
Simpleware develops industry-leading software solutions for the conversion of 3D images (as obtained from MRI, CT, micro-CT…) into high-quality Computer-aided Engineering (CAE), Computer-aided Design (CAD) and 3D printing models. Simpleware software is used by engineers and researchers in a variety of fields, including: Life Sciences, Materials Science, Oil and Gas Exploration, Industrial Non-Destructive Evaluation and Reverse Engineering. Simpleware software is based on proprietary technology that facilitates the integration of image data with CAD and computational analysis (finite element and computational fluid dynamics) workflows. Unlike other approaches, Simpleware provides the most comprehensive software solution for bridging 3D image data and commercial CAE solvers, CAD packages, and 3D printing.
For more information on Simpleware, please visit: http://www.simpleware.com