# K970617: CT-Modeller System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Apr 21, 1997 after 62 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: 1 generation back to K924630 (1993). 1 ancestor in all.
380 later devices descend from it; 2 cite it directly.
0 of 382 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924630: Surgicad (TM) View (TM), Surgicad Corp. (1993) Summary page 1.

## Most influential descendants
- K033849: Simplant System (2004), 379 descendants of its own
- K073449: Surgicase (2008), 143 descendants of its own
- K073468: Mimics (2008), 141 descendants of its own
- K102795: Signature Planner; Signature Guides (2011), 99 descendants of its own
- K111863: Signature Planner,Signature Guides (2012), 71 descendants of its own

## Indications for use
The Materialise CT-Modeller System 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 Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System. The CT-Modeller System which is the subject of this 510(k) premarket notification is confined solely to the software image segmentation system.

Source page: https://510kreport.com/device/K970617
Methodology: https://510kreport.com/methodology