510(k) · Cleared
ClearedVisitrak, Version 1, Release 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Math Resolutions, LLC · IYE Accelerator, Linear, Medical
Cleared on Mar 25, 2005 as substantially equivalent to K970464 (Northwest Medical Physics Equipment, Inc., 1997) after a 39-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 25, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970464 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970464 P Reference TPS (Treatment Planning Software) 1.1Northwest Medical Physics Equipment, Inc. · 1997
- This deviceK050372 Visitrak, Version 1, Release 1Math Resolutions, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970464 | P Reference TPS (Treatment Planning Software) 1.1 | Northwest Medical Physics Equipment, Inc. | 1997 | — |
| 0 (this device) | K050372 | Visitrak, Version 1, Release 1 | Math Resolutions, LLC | 2005 | — |
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 |
|---|---|---|---|
| * | K970464 | P Reference TPS (Treatment Planning Software) 1.1Summary page 1…ed radiation therapy. Regulatory Class is II. A predicate device is Acculoc from Northwest Medical Physics Equipment, 21031 6 7t1h Ave. West, Lynnwood, WA 98036, 510(k) K970464. VisiTrak and Acculoc both mathematically solves for the x,y,z coordinates of the couch so that the projected image of a designat… | 1997 |
| † | K993530 | System 2100 | 1999 |
| † | K010225 | Dosimetry Check | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K970464.
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?
This product is to be used by radiation therapy oncologist or staff under their direction to locate the position relative to the patient of the isocenter of a treatment beam on a gantry mounted radiation therapy treatment machine. Some internal or external marker must be visible on both a radiograph of the patient taken at the time of treatment and the images used for the treatment plan in order to use this software to align the marker image on the…
Read the full statement (118 words)
This product is to be used by radiation therapy oncologist or staff under their direction to
locate the position relative to the patient of the isocenter of a treatment beam on a gantry
mounted radiation therapy treatment machine. Some internal or external marker must be
visible on both a radiograph of the patient taken at the time of treatment and the images
used for the treatment plan in order to use this software to align the marker image on the
radiograph with the plan to find the proper patient support system coordinates. Only a
translation along the couch lateral, longitudinal, and height directions are considered and
solved for. Possible rotations or repositioning of the patient are not considered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050372: Visitrak, Version 1, Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050372
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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