510(k) · Cleared
ClearedVenusX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linatech, LLC · IYE Accelerator, Linear, Medical
Cleared on Apr 12, 2024 as substantially equivalent to K101751 (Varian Medical Systems, Oncology Systems, 2010) after a 239-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Apr 12, 2024
- Review
- 239 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913119 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
- 5 generations backK033343 Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc. · 2003 · Recalled
- 4 generations backK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
- 3 generations backK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK101751 Varian Unique Single Energy Linear AcceleratorVarian Medical Systems, Oncology Systems · 2010 · Recalled
- This deviceK232489 VenusXLinatech, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913119 | Varian C-Series Clinacs (Clinac 2300C/D) | Varian Assoc., Inc. | 1991 | 6 |
| −5 | K033343 | Trilogy Radiotherapy Delivery System | Varian Medical Systems, Inc. | 2003 | 3 |
| −4 | K061140 | Trilogy Radiotherapy Delivery System | Varian Medical Systems | 2006 | — |
| −3 | K070094 | Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System | Varian Medical Systems, Inc. | 2007 | 5 |
| −2 | K072916 | Trilogy System with Rapidarc | Varian Medical Systems, Inc. | 2007 | 2 |
| −1 | K101751 | Varian Unique Single Energy Linear Accelerator | Varian Medical Systems, Oncology Systems | 2010 | 1 |
| 0 (this device) | K232489 | VenusX | Linatech, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K101751 | Varian Unique Single Energy Linear AcceleratorSummary page 4…21 CFR §892.5050 Regulatory Class: Class II Product Code: IYE III. PREDICATE DEVICE Predicate Devices: Varian UNIQUE (K101751) Reference Device: Varian On Board Imaging (OBI) (K042720) IV. DEVICE DESCRIPTION Device Description: T… | 2010 |
| † | K042720 | ON-Board Imager Device | 2004 |
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?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K101751.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232489: VenusX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232489
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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