Regulatory Information

Simpleware ScanIP has 510(k) marketing clearance from the U.S. Food & Drug Administration in the United States.

FDA 510(k) Premarket Notification

Indications for Use

"Simpleware 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."

Instructions for Use

The Instructions for Use (IFU) for Simpleware ScanIP is available to download in an electronic format:

Minimum requirements for viewing IFU:

  • PDF viewer

Version History:

The first Instructions for Use was issued for the Simpleware N-2018.03 release.

The current release is O-2018.12.

Past Instructions for Use:

  • N-2018.03 Instructions for Use (English)