![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Synopsys Simpleware’s 3D Diagnostic Printing Software Gets 510(k) Clearance
Synopsys Simpleware’s 3D Diagnostic Printing Software Gets 510(k) Clearance
![ClearanceStamp_Blue.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Blue.gif?t=1576043968&width=430)
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.
Upcoming Events
-
21Oct