# K203195: Simpleware ScanIP Medical

- Pathway: 510(k) (Traditional)
- Applicant: Synopsys (Northern Europe), Ltd.
- Decided: Apr 1, 2021 after 155 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142779: Scanip; Scanip: Medical Edition; Scanip: Med, Simpleware, Ltd. (2015) Summary page 4.

## Most influential descendants
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own
- K243069: Lumys (V1) (2025), 0 descendants of its own
- K241961: Vent Creativity Knee v1.0 (Hermes) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K203195
Methodology: https://510kreport.com/methodology