510(k) · Cleared
Recalled · Class II · 2014Exactrac 5.5
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 26, 2007 as substantially equivalent to K040585 (Brainlab AG, 2004) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1987. 15 later devices descend from it. It has been recalled once.
- Decided
- Oct 26, 2007
- Review
- 50 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K864886 (1987). 5 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 2 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 1 generation backK033287 Exactrac GatingBrainlab AG · 2003
- This deviceK072506 Exactrac 5.5Brainlab AG · 2007
- Descendant · cites it directly · 8 of its ownK120789 Exactrac X-Ray X-RayBrainlab AG · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK201276 ExacTrac DynamicBrainlab AG · 2020 · Recalled
- Descendant · cites it directly · 5 of its ownK080742 Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008
- Descendant · 3 generations on · 3 of its ownK220338 ExacTrac DynamicBrainlab AG · 2022 · Recalled
- Descendant · 2 generations on · 3 of its ownK092653 Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH · 2009
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K120789Exactrac X-Ray X-RayBrainlab AG · 2012 · cites it directly8descendants
- K201276ExacTrac DynamicBrainlab AG · 2020 · 2 generations on6descendants
- K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008 · cites it directly5descendants
- K220338ExacTrac DynamicBrainlab AG · 2022 · 3 generations on3descendants
- K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH · 2009 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −2 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −1 | K033287 | Exactrac Gating | Brainlab AG | 2003 | — |
| 0 (this device) | K072506 | Exactrac 5.5 | Brainlab AG | 2007 | — |
| +1 | K120789 | Exactrac X-Ray X-Ray | Brainlab AG | 2012 | 6 |
| +2 | K201276 | ExacTrac Dynamic | Brainlab AG | 2020 | 1 |
| +1 | K080742 | Verisuite 1.6, Verisuite-Particle 1.6 | Medcom GmbH | 2008 | — |
| +3 | K220338 | ExacTrac Dynamic | Brainlab AG | 2022 | 1 |
| +2 | K092653 | Verisuite and Verisuite-Particle, Version 1.8 | Medcom GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (2)
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…892.5050 Regulatory Class Class II FDA Establishment Registration 804 39 33 Number Predicate Device ExacTrac 4.0(K040585) ExacTrac Gating (K033287) X-ray Generator Device Classification Name: Generator, High Voltage X-Ray, Diagnostic Regulatory Cla… | 2004 |
| * | K033287 | Exactrac GatingSummary page 1…50 Regulatory Class Class II FDA Establishment Registration 804 39 33 Number Predicate Device ExacTrac 4.0(K040585) ExacTrac Gating (K033287) X-ray Generator Device Classification Name: Generator, High Voltage X-Ray, Diagnostic Regulatory Class: Class I Exempt Accessi… | 2003 |
What descends from it? (15)
See all 153 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2014 | Class II | Z-1707-2014 | Software design | When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K120789 (Brainlab AG, 2012) has gone furthest, with 8 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?
ExacTrac is a system that is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac system uses optical tracking of infrared markers and x-ray registration to determine and correct the position of the patient. With the additional ExacTrac gating module, the treatment beam is gated in accordance with the patient's breathing level.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072506: Exactrac 5.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072506
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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