510(k) · Cleared
Recalled · Class II · 2018Exactrac X-Ray X-Ray
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 Aug 14, 2012 as substantially equivalent to K072506 (Brainlab AG, 2007) and 1 other predicate after a 152-day review. Its family tree reaches back 4 generations to 1996. 8 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 14, 2012
- Review
- 152 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963624 (1996). 11 ancestors in all, the oldest K864886 (1987). 8 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 3 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 2 generations backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- 1 generation backK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · Recalled
- This deviceK120789 Exactrac X-Ray X-RayBrainlab AG · 2012
- Descendant · cites it directly · 6 of its ownK201276 ExacTrac DynamicBrainlab AG · 2020 · Recalled
- Descendant · 2 generations on · 3 of its ownK220338 ExacTrac DynamicBrainlab AG · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK240431 ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG · 2024
- Descendant · 4 generations on · 0 of its ownK254010 ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE · 2026
- Descendant · 3 generations on · 0 of its ownK231052 ExacTrac Dynamic 1.1.2Brainlab AG · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K201276ExacTrac DynamicBrainlab AG · 2020 · cites it directly6descendants
- K220338ExacTrac DynamicBrainlab AG · 2022 · 2 generations on3descendants
- K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG · 2024 · 3 generations on1descendant
- K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE · 2026 · 4 generations on0descendants
- K231052ExacTrac Dynamic 1.1.2Brainlab AG · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −3 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −2 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| −1 | K042720 | ON-Board Imager Device | Varian Medical Systems | 2004 | 5 |
| 0 (this device) | K120789 | Exactrac X-Ray X-Ray | Brainlab AG | 2012 | — |
| +1 | K201276 | ExacTrac Dynamic | Brainlab AG | 2020 | 1 |
| +2 | K220338 | ExacTrac Dynamic | Brainlab AG | 2022 | 1 |
| +3 | K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG | 2024 | — |
| +4 | K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | 2026 | — |
| +3 | K231052 | ExacTrac Dynamic 1.1.2 | Brainlab AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K072506 | Exactrac 5.5Summary page 1…ficatian Patient Positioning System with respiratory Gating, Radiation Therapy, Name: Charged-Particle, Medical Predicate Device: ExacTrac 5.5 (K072506) Varian On-Board Imager Device (K042720) Device classification System, Radiation Therapy, Charged-Parti… | 2007 |
| * | K042720 | ON-Board Imager DeviceSummary page 1…adiation Therapy, Name: Charged-Particle, Medical Predicate Device: ExacTrac 5.5 (K072506) Varian On-Board Imager Device (K042720) Device classification System, Radiation Therapy, Charged-Particle, Medical name: Regulatory Class: Class 11 Regulation N… | 2004 |
What descends from it? (8)
2 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 |
|---|---|---|---|---|
| Feb 14, 2018 | Class II | Z-1006-2018 | Other | The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam… |
| Aug 5, 2015 | Class II | Z-2440-2015 | Software in the Use Environment | ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification. |
| Mar 6, 2015 | Class II | Z-1582-2015 | Software in the Use Environment | ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees. |
| Feb 16, 2015 | Class II | Z-1316-2015 | Software in the Use Environment | The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT. |
| Jun 24, 2014 | Class II | Z-2146-2014 | Software design | When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this… |
| Feb 24, 2014 | Class II | Z-1513-2014 | Software design | When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K201276 (Brainlab AG, 2020) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K072506.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120789: Exactrac X-Ray X-Ray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120789
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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