# K111642: Onco Trac Model 1, 2, 4

- Pathway: 510(k) (Traditional)
- Applicant: Translational Sciences Corporation
- Decided: Nov 18, 2011 after 158 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 K945188 (1995). 17 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081985: AW Server, Ge Medical Systems, LLC (2008) Summary page 1.

## Most influential descendants
- K142647: mint Lesion (2015), 2 descendants of its own
- K220929: Excelsior (2022), 0 descendants of its own
- K202229: AI Metrics (2020), 0 descendants of its own

## Indications for use
OncoTraCTM is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MMJ, measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report. OncoTracTM is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. OncocTM does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function. OncoTracTM is not intended for use for mammography.

Source page: https://510kreport.com/device/K111642
Methodology: https://510kreport.com/methodology