510(k) · Cleared
ClearedExactrac (Brainlab Patient Positioning System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jul 14, 1999 after a 268-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 32 later devices descend from it.
- Decided
- Jul 14, 1999
- Review
- 268 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 3 citing it directly.
- This deviceK983660 Exactrac (Brainlab Patient Positioning System)Brainlab, Inc. · 1999
- Descendant · cites it directly · 18 of its ownK052682 AlignrtVision RT Limited · 2006 · Recalled
- Descendant · 2 generations on · 12 of its ownK072171 Gatect-RTVision RT Limited · 2007
- Descendant · cites it directly · 11 of its ownK060906 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK123371 Alignrt PlusVision RT Limited · 2013 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K052682AlignrtVision RT Limited · 2006 · cites it directly18descendants
- K072171Gatect-RTVision RT Limited · 2007 · 2 generations on12descendants
- K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006 · cites it directly11descendants
- K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 2 generations on9descendants
- K123371Alignrt PlusVision RT Limited · 2013 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983660 | Exactrac (Brainlab Patient Positioning System) | Brainlab, Inc. | 1999 | — |
| +1 | K052682 | Alignrt | Vision RT Limited | 2006 | 1 |
| +2 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| +1 | K060906 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2006 | — |
| +2 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| +2 | K123371 | Alignrt Plus | Vision RT Limited | 2013 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (32)
See all 323 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?
- Of its descendants, K052682 (Vision RT Limited, 2006) has gone furthest, with 18 descendants of its own.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
This submission describes 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 System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983660: Exactrac (Brainlab Patient Positioning System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983660
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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