# K001163: DMLC IV-Ergo

- Pathway: 510(k) (Traditional)
- Applicant: 3D Line USA, Inc.
- Decided: Oct 23, 2000 after 196 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
69 later devices descend from it; 5 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032762: Xio Radiation Treatment Planning System (2003), 52 descendants of its own
- K092132: Xio RTP System (2009), 34 descendants of its own
- K013535: Evtool Model # V. 1.0 (2002), 30 descendants of its own
- K080601: Ergo++ Version 1.7 (2008), 29 descendants of its own
- K102216: Xio RTP System (2010), 27 descendants of its own

## Recalls of this device
- Aug 15, 2013 · Class II · Z-2157-2013: Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
- May 1, 2013 · Class II · Z-0978-2014: It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
- May 25, 2011 · Not classified · Z-0014-2012: It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).

Source page: https://510kreport.com/device/K001163
Methodology: https://510kreport.com/methodology