# K033955: RTIST

- Pathway: 510(k) (Traditional)
- Applicant: Mirada Solutions, Ltd.
- Decided: Mar 17, 2004 after 86 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: 6 generations back to K954678 (1996). 13 ancestors in all.
75 later devices descend from it; 4 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013878: Cybermed, Inc., V-Works, Cybermed, Inc. (2001) Summary page 3.
- K031013: Infintt CO., LTD. Starpacs System, Infinitt Company (2003) Summary page 3.
- K032483: Viatronix V3D Explorer, Revision 1.2, Viatronix, Inc. (2003) Summary page 3.
- K030457: Rex, Version 3.0, Pointdx, Inc. (2003) Summary page 3.
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 3.

## Most influential descendants
- K101228: Mirada XD (2010), 70 descendants of its own
- K102687: Mirada RT (2010), 37 descendants of its own
- K130393: Mirada RTX (2013), 36 descendants of its own
- K181572: Workflow Box (2018), 25 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own

## Indications for use
RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware. The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of 'avoidance' structure(s) during critical evaluation. Typical users of this system are trained professionals, including but not limited to radiologists, clinicians and technicians. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.

Source page: https://510kreport.com/device/K033955
Methodology: https://510kreport.com/methodology