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Synopsys Simpleware’s 3D Diagnostic Printing Software Gets 510(k) Clearance

June 15, 2021

The FDA has granted 510(k) clearance to Synopsys Simpleware’s ScanIP Medical 3D diagnostic printing software.

The 3D image-segmentation system, which is intended for use in diagnosis and for planning surgical procedures, transfers the imaging information to an output file.

The Mountain View, Calif., company previously received a CE mark certification and ISO certification for the software.

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