# K013535: Evtool Model # V. 1.0

- Pathway: 510(k) (Traditional)
- Applicant: 3D Line USA, Inc.
- Decided: Jan 18, 2002 after 87 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K001163 (2000). 1 ancestor in all.
30 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001163: DMLC IV-Ergo, 3D Line USA, Inc. (2000) Summary page 1.

## Most influential descendants
- K080601: Ergo++ Version 1.7 (2008), 29 descendants of its own
- K141572: Mosaiq Oncology Information System (2014), 13 descendants of its own
- K183034: MOSAIQ Oncology Information System (2018), 12 descendants of its own
- K091179: Monaco RTP System, Vmat Option (2009), 12 descendants of its own
- K203172: MOSAIQ Oncology Information System (2020), 8 descendants of its own

## Indications for use
EVTOOL software module provides the ability to compare and evaluate the radiation dose delivery to the tumor volume and surrounding organs from generated dose volume histograms and radiobiological values. It expands the DMLC IV-ERGO system, which is a combination of a radiation collimator with multiple tungsten leaves that move during delivery of radiation therapy and a computer based treatment planning and control system.

Source page: https://510kreport.com/device/K013535
Methodology: https://510kreport.com/methodology