510(k) · Cleared

Recalled · Class II · 2013

DMLC IV-Ergo

K001163510(k) TraditionalCleared Oct 23, 2000196-day reviewClass II21 CFR 892.5710Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

3D Line USA, Inc. · IXI Block, Beam-Shaping, Radiation Therapy

Cleared on Oct 23, 2000 after a 196-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 69 later devices descend from it. It has been recalled 3 times.

Decided: Oct 23, 2000
Review: 196 days
Class: Class II
Product code: IXI
Recalls: 3
Predicates: 0

69 later devices descend from it, 5 citing it directly.

This deviceK001163 DMLC IV-Ergo3D Line USA, Inc. · 2000
Descendant · cites it directly · 52 of its ownK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
Descendant · 2 generations on · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
Descendant · cites it directly · 30 of its ownK013535 Evtool Model # V. 1.03D Line USA, Inc. · 2002
Descendant · cites it directly · 29 of its ownK080601 Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · Recalled
Descendant · 3 generations on · 27 of its ownK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2002high 6 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 69 · See all

K032762Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003 · cites it directly52descendants
K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · 2 generations on34descendants
K013535Evtool Model # V. 1.03D Line USA, Inc. · 2002 · cites it directly30descendants
K080601Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · cites it directly29descendants
K102216Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · 3 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001163	DMLC IV-Ergo	3D Line USA, Inc.	2000	—
+1	K032762	Xio Radiation Treatment Planning System	Computerized Medical Systems, Inc.	2003	—
+2	K092132	Xio RTP System	Computerized Medical Systems, Inc.	2009	12
+1	K013535	Evtool Model # V. 1.0	3D Line USA, Inc.	2002	—
+1	K080601	Ergo++ Version 1.7	3D Line Medical Systems S.R.L.	2008	2
+3	K102216	Xio RTP System	Computerized Medical Systems, Inc.	2010	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2006	3	0
2007	1	0
2008	1	0
2009	5	0
2010	3	0
2011	2	0
2013	2	0
2014	3	0
2015	3	0
2016	2	0
2017	4	0
2018	6	0
2019	5	0
2020	5	0
2021	4	0
2022	5	0
2023	4	0
2024	3	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K001163, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IXI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IXI device

#1 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (69)

See all 69

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032762	Xio Radiation Treatment Planning System	Computerized Medical Systems, Inc.	2003	52
K013535	Evtool Model # V. 1.0	3D Line USA, Inc.	2002	30
K080601	Ergo++ Version 1.7	3D Line Medical Systems S.R.L.	2008	29
K040474	Accusoft	Direx Systems Corp.	2004	2
K111676	APEX	Elekta Limited	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 15, 2013	Class II	Z-2157-2013	Device Design	Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
May 1, 2013	Class II	Z-0978-2014	Component design/selection	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	Device Design	It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K032762 (Computerized Medical Systems, Inc., 2003) has gone furthest, with 52 descendants of its own.

How does its category compare?

All IXI devices

IXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXI

2in 2022

2007high 3 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXI

90in 2013

2007high 90 (2013) · low 78 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IXI

2in 2013

2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IXI

1in 2016

2007high 28 (2011) · low 0 (2007)2025

MAUDE reports naming product code IXI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	0	—	1	0
2009	3	78	0	0
2010	0	—	0	1
2011	2	—	1	28
2012	1	—	1	3
2013	3	90	2	2
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	1
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	2	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	1	—	0	—

https://510kreport.com/device/K001163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001163: DMLC IV-Ergo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001163

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026