# K173542: Arterys Oncology DL

- Pathway: 510(k) (Traditional)
- Applicant: Arterys, Inc.
- Decided: Jan 25, 2018 after 70 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: 10 generations back to K913770 (1991). 93 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101749: Syngo Trued Software, Siemens Medical Solutions (2010) Summary page 4.

## Most influential descendants
- K182034: Arterys MICA (2018), 3 descendants of its own
- K192437: Arterys MICA (2020), 2 descendants of its own
- K203744: Arterys MICA (2022), 1 descendant of its own
- K252539: Tempus Pixel (2025), 0 descendants of its own
- K192969: Ezra Plexo Software (2020), 0 descendants of its own

## Indications for use
Arterys Oncology DL is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. Arterys Oncology DL enables visualization of information that would otherwise have to be visually compared disjointedly. Arterys Oncology DL provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. Arterys Oncology DL is designed to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Arterys Oncology DL is a complement to these standard procedures.

Source page: https://510kreport.com/device/K173542
Methodology: https://510kreport.com/methodology