# K173420: Radiomics App v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Microsoft Corp.
- Decided: Dec 27, 2017 after 56 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: 9 generations back to K954874 (1996). 53 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103576: Mim 5.2 (Brachy), Mim Software, Inc. (2011) Summary page 4.

## Most influential descendants
- K201232: Limbus Contour (2020), 2 descendants of its own
- K230575: Limbus Contour (2023), 1 descendant of its own
- K241837: Limbus Contour (2024), 0 descendants of its own
- K232045: MeVis Liver Suite (2023), 0 descendants of its own

## Indications for use
Microsoft Radiomics App v1.0 is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal organ and tumor contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. Radiomics App assists in the following scenarios: • Load, save and display of medical images and contours for treatment evaluation and treatment planning. • Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy, and archiving contours for patient follow-up. • Localization and definition of both solid tumors and healthy anatomical structures. • Fusion display of compatible images for treatment planning. • Three-dimensional rendering of medical images and the segmented contours. Images reviewed using the Radiomics App software should not be used for primary image interpretations. Radiomics App is not for use with digital mammography.

Source page: https://510kreport.com/device/K173420
Methodology: https://510kreport.com/methodology