Simpleware ScanIP has 510(k) marketing clearance from the U.S. Food & Drug Administration in the United States.
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Regulatory Information
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:
- Instructions for Use (English)
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 N-2018.03.