510(k) · Cleared

Recalled · 2003

Odyssey LX, Model 211320

K003437510(k) TraditionalCleared Feb 2, 200188-day reviewClass II21 CFR 892.2050Recalls 1

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

Philips Medical Systems (Cleveland), Inc. · LLZ System, Image Processing, Radiological

Cleared on Feb 2, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it. It has been recalled once.

Decided: Feb 2, 2001
Review: 88 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 0

42 later devices descend from it, 3 citing it directly.

This deviceK003437 Odyssey LX, Model 211320Philips Medical Systems (Cleveland), Inc. · 2001
Descendant · cites it directly · 27 of its ownK013673 HI-Art SystemTomo Therapy, Inc. · 2002
Descendant · 2 generations on · 26 of its ownK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
Descendant · 3 generations on · 25 of its ownK042739 HI-Art SystemTomotherapy Incorporated · 2004
Descendant · 4 generations on · 24 of its ownK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
Descendant · 5 generations on · 13 of its ownK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2002high 4 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 42 · See all

K013673HI-Art SystemTomo Therapy, Inc. · 2002 · cites it directly27descendants
K033347Modification to: HI-Art SystemTomotherapy Incorporated · 2003 · 2 generations on26descendants
K042739HI-Art SystemTomotherapy Incorporated · 2004 · 3 generations on25descendants
K060912Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · 4 generations on24descendants
K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · 5 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003437	Odyssey LX, Model 211320	Philips Medical Systems (Cleveland), Inc.	2001	—
+1	K013673	HI-Art System	Tomo Therapy, Inc.	2002	—
+2	K033347	Modification to: HI-Art System	Tomotherapy Incorporated	2003	—
+3	K042739	HI-Art System	Tomotherapy Incorporated	2004	—
+4	K060912	Modification to: HI-Art System	Tomotherapy Incorporated	2006	4
+5	K082005	Modification to HI-Art Treatment System	Tomotherapy Incorporated	2008	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2008	1	0
2009	3	0
2010	2	0
2011	3	0
2012	3	0
2013	2	0
2014	2	0
2015	2	0
2016	2	0
2017	3	0
2018	4	0
2020	3	0
2021	2	0
2023	4	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K003437, 2001–2026Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K013673	HI-Art System	Tomo Therapy, Inc.	2002	27
K101279	CORRIDOR4DM V2010 Model: V2010	Invia	2010	12
K230393	UniCam Evo Software	Inter Medical Medizintechnik GmbH	2023	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 15, 2003	Not classified	Z-0093-04	Other	Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K013673 (Tomo Therapy, Inc., 2002) has gone furthest, with 27 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

https://510kreport.com/device/K003437 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003437: Odyssey LX, Model 211320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003437

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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