510(k) · Cleared
Recalled · Class II · 2023ExacTrac Dynamic
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 Apr 29, 2022 as substantially equivalent to K201276 (Brainlab AG, 2020) after an 81-day review. Its family tree reaches back 6 generations to 1996. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 29, 2022
- Review
- 81 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963624 (1996). 13 ancestors in all, the oldest K864886 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 5 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 4 generations backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · Recalled
- 2 generations backK120789 Exactrac X-Ray X-RayBrainlab AG · 2012 · Recalled
- 1 generation backK201276 ExacTrac DynamicBrainlab AG · 2020 · Recalled
- This deviceK220338 ExacTrac DynamicBrainlab AG · 2022
- Descendant · cites it directly · 1 of its ownK240431 ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG · 2024
- Descendant · 2 generations on · 0 of its ownK254010 ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE · 2026
- Descendant · cites it directly · 0 of its ownK231052 ExacTrac Dynamic 1.1.2Brainlab AG · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −5 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −4 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| −3 | K042720 | ON-Board Imager Device | Varian Medical Systems | 2004 | 5 |
| −2 | K120789 | Exactrac X-Ray X-Ray | Brainlab AG | 2012 | 6 |
| −1 | K201276 | ExacTrac Dynamic | Brainlab AG | 2020 | 1 |
| 0 (this device) | K220338 | ExacTrac Dynamic | Brainlab AG | 2022 | — |
| +1 | K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG | 2024 | — |
| +2 | K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K201276 | ExacTrac DynamicSummary page 4…namic Product Code IYE Regulation Number 892.5050 Regulatory Class II Panel Radiology Predicate Devices ExacTrac Dynamic (K201276) 1. Indications for Use ExacTrac Dynamic is intended to position patients at an accurately defined point within the… | 2020 |
What descends from it? (3)
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, 2023 | Class II | Z-1259-2023 | Software design | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K240431 (Brainlab AG, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K201276.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220338: ExacTrac Dynamic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220338
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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