510(k) · Cleared
ClearedExactrac 4.0 and Exactrac X-Ray 6D
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 May 11, 2004 as substantially equivalent to K003285 (Brainlab AG, 2001) after a 67-day review. Its family tree reaches back 1 generation to 2001. 41 later devices descend from it.
- Decided
- May 11, 2004
- Review
- 67 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003285 (2001). 41 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK003285 Exac Trac 2.0 (Novalis Body Module)Brainlab AG · 2001
- This deviceK040585 Exactrac 4.0 and Exactrac X-Ray 6DBrainlab AG · 2004
- Descendant · cites it directly · 15 of its ownK072506 Exactrac 5.5Brainlab AG · 2007 · Recalled
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 10 of its ownK122451 Exactrac VeroBrainlab AG · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K072506Exactrac 5.5Brainlab AG · 2007 · cites it directly15descendants
- K072046Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemBrainlab AG · 2007 · cites it directly13descendants
- K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006 · cites it directly11descendants
- K122451Exactrac VeroBrainlab AG · 2012 · 2 generations on10descendants
- K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003285 | Exac Trac 2.0 (Novalis Body Module) | Brainlab AG | 2001 | — |
| 0 (this device) | K040585 | Exactrac 4.0 and Exactrac X-Ray 6D | Brainlab AG | 2004 | — |
| +1 | K072506 | Exactrac 5.5 | Brainlab AG | 2007 | 1 |
| +1 | 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 | — |
| +2 | K122451 | Exactrac Vero | Brainlab AG | 2012 | 2 |
| +2 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K003285 | Exac Trac 2.0 (Novalis Body Module)Summary page 1…Patient Positioning System / System, Radiation Therapy, Charged- Particle, Medical Predicate Device: ExacTrac (K003285) Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical Regulatory Class: Class II X-ray Generator D… | 2001 |
What descends from it? (41)
See all 415 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?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ExacTrac 4.0 is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040585: Exactrac 4.0 and Exactrac X-Ray 6D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040585
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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