Simpleware Software Regulatory Information

Simpleware ScanIP Medical has CE Marking, FDA 510(k) marketing clearance, and ISO 13485:2016 certification.  

CE Marking Certificate

FDA 510(k) Premarket Notification

ISO 13485:2016 Certificate

Please note that only the Simpleware ScanIP Medical edition is available for the below Indications for Use.

Indications for Use (FDA 510(k))

Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning.

For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.

The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.

For a list of printers cleared for diagnostic 3D printing use, please visit our Point-of-Care (POC) 3D Printing page.

Indications for Use (CE Marking)

Simpleware ScanIP Medical 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. Simpleware ScanIP Medical is not intended to be used for mammography imaging.

The general version of Simpleware ScanIP is intended only for research purposes. It is intended to be used for visualization, analysis and model generation of a variety of imaging formats, including for biomedical research. However, this version must not be used, and is not intended to be used, for any medical or clinical purpose whatsoever.

Instructions for Use

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

• Instructions for Use (English)

Minimum requirements for viewing IFU:

• PDF viewer

Instructions for Use in Other Languages:

• Croatian
• Czech
• Danish
• Dutch
• Estonian
• Finnish
• French
• German
• Greek (for Cyprus)
• Hungarian
• Icelandic
• Italian
  
• Polish
• Slovenian
• Spanish
  

Version History:

The first Instructions for Use was issued for the Simpleware N-2018.03 release, prior to CE marking.*

The current release is S-2021.06

*Please note that the first Instructions for Use for non-English languages begin from O-2018.12.

Past Instructions for Use:

• R-2021.03 Instructions for Use (English)
• R-2020.09 Instructions for Use (English)
• Q-2020.06 Instructions for Use (English)
• Q-2020.03 Instructions for Use (English)
• P-2019.09 Instructions for Use (English)
• O-2018.12 Instructions for Use (English)
  
• N-2018.03 Instructions for Use (English)