510(k) · Cleared
ClearedExactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · IYE Accelerator, Linear, Medical
Cleared on Oct 17, 2007 as substantially equivalent to K040585 (Brainlab AG, 2004) after an 84-day review. Its family tree reaches back 2 generations to 2001. 13 later devices descend from it.
- Decided
- Oct 17, 2007
- Review
- 84 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003285 (2001). 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003285 Exac Trac 2.0 (Novalis Body Module)Brainlab AG · 2001
- 1 generation backK040585 Exactrac 4.0 and Exactrac X-Ray 6DBrainlab AG · 2004
- This deviceK072046 Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemBrainlab AG · 2007
- Descendant · cites it directly · 10 of its ownK122451 Exactrac VeroBrainlab AG · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK131965 XVI R5.0Elekta Limited · 2013
- Descendant · 3 generations on · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
- Descendant · 5 generations on · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K122451Exactrac VeroBrainlab AG · 2012 · cites it directly10descendants
- K131965XVI R5.0Elekta Limited · 2013 · 2 generations on8descendants
- K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · 3 generations on4descendants
- K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 4 generations on3descendants
- K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003285 | Exac Trac 2.0 (Novalis Body Module) | Brainlab AG | 2001 | — |
| −1 | K040585 | Exactrac 4.0 and Exactrac X-Ray 6D | Brainlab AG | 2004 | — |
| 0 (this device) | K072046 | Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem | Brainlab AG | 2007 | — |
| +1 | K122451 | Exactrac Vero | Brainlab AG | 2012 | 2 |
| +2 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| +3 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| +4 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
| +5 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040585 | Exactrac 4.0 and Exactrac X-Ray 6DSummary page 1…Patient Positioning System / System, Radiation Therapy, Charged- Particle, Medical Predicate Device: ExacTrac 4.0 (K040585) Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical Regulatory Class: Class II… | 2004 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122451 (Brainlab AG, 2012) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K040585.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 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 | — |
What is it indicated for?
The ExacTrac 3rd Party system is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd.
ExacTrac 3rd Party uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator.
The ExacTrac 3rd Party system uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072046: Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072046
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026