510(k) · Cleared

Cleared

Exac Trac 2.0 (Novalis Body Module)

K003285510(k) TraditionalCleared Jul 31, 2001285-day reviewClass II21 CFR 892.5050

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

Brainlab AG · IYE Accelerator, Linear, Medical

Cleared on Jul 31, 2001 after a 285-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 58 later devices descend from it.

Decided: Jul 31, 2001
Review: 285 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

58 later devices descend from it, 6 citing it directly.

This deviceK003285 Exac Trac 2.0 (Novalis Body Module)Brainlab AG · 2001
Descendant · cites it directly · 41 of its ownK040585 Exactrac 4.0 and Exactrac X-Ray 6DBrainlab AG · 2004
Descendant · cites it directly · 16 of its ownK033287 Exactrac GatingBrainlab AG · 2003
Descendant · 2 generations on · 15 of its ownK072506 Exactrac 5.5Brainlab AG · 2007 · Recalled
Descendant · 2 generations on · 13 of its ownK072046 Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemBrainlab AG · 2007
Descendant · cites it directly · 11 of its ownK060906 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2003high 7 (2012) · low 1 (2005)2026

Most influential descendants

Showing 5 of 58 · See all

K040585Exactrac 4.0 and Exactrac X-Ray 6DBrainlab AG · 2004 · cites it directly41descendants
K033287Exactrac GatingBrainlab AG · 2003 · cites it directly16descendants
K072506Exactrac 5.5Brainlab AG · 2007 · 2 generations on15descendants
K072046Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemBrainlab AG · 2007 · 2 generations on13descendants
K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006 · cites it directly11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003285	Exac Trac 2.0 (Novalis Body Module)	Brainlab AG	2001	—
+1	K040585	Exactrac 4.0 and Exactrac X-Ray 6D	Brainlab AG	2004	—
+1	K033287	Exactrac Gating	Brainlab AG	2003	—
+2	K072506	Exactrac 5.5	Brainlab AG	2007	1
+2	K072046	Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem	Brainlab AG	2007	—
+1	K060906	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	1	0
2006	4	0
2007	2	0
2008	3	0
2009	2	0
2010	1	0
2011	1	0
2012	7	0
2013	3	0
2014	4	0
2015	2	0
2016	2	0
2017	1	0
2018	3	0
2019	3	0
2020	3	0
2021	3	0
2022	2	0
2023	2	0
2024	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K003285, 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 IYE? 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 IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (58)

See all 58

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

Number	Device	Applicant	Decided	Descendants
K040585	Exactrac 4.0 and Exactrac X-Ray 6D	Brainlab AG	2004	41
K033287	Exactrac Gating	Brainlab AG	2003	16
K060906	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2006	11
K062611	Iguide System	Medical Intelligence Medizintechnik-GmbH-An Elekta	2006	7
K032100	I-BEAM	Computerized Medical Systems, Inc.	2003	4
K042110	Beamcath	Beampoint AB	2005	3

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K040585 (Brainlab AG, 2004) has gone furthest, with 41 descendants of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

https://510kreport.com/device/K003285 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003285: Exac Trac 2.0 (Novalis Body Module).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003285

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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