# K142779: Scanip; Scanip: Medical Edition; Scanip: Med

- Pathway: 510(k) (Traditional)
- Applicant: Simpleware, Ltd.
- Decided: Apr 17, 2015 after 203 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924630 (1993). 5 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K073468: Mimics, Materialise NV (2008) Summary page 4.

## Most influential descendants
- K203195: Simpleware ScanIP Medical (2021), 3 descendants of its own
- 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

## Recalls of this device
- Jun 4, 2021 · Class II · Z-2254-2021: A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstan
- Jun 4, 2021 · Class II · Z-2253-2021: A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstan

## Indications for use
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 a Magnetic Resonance Imaging scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options. ScanIP is not intended to be used for mammography imaging.

Source page: https://510kreport.com/device/K142779
Methodology: https://510kreport.com/methodology