510(k) · Cleared
ClearedRadionics Xknife HDRT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Radionics, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Mar 2, 2009 as substantially equivalent to K081188 (Varian Medical Systems, Inc., 2008) after a 104-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Mar 2, 2009
- Review
- 104 days
- Class
- Class II
- Product code
- MUJ
- 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 backK081188 Trilogy with External System Gating InterfaceVarian Medical Systems, Inc. · 2008 · Recalled
- This deviceK083414 Radionics Xknife HDRT SystemIntegra Radionics, Inc. · 2009
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 | K081188 | Trilogy with External System Gating Interface | Varian Medical Systems, Inc. | 2008 | 1 |
| 0 (this device) | K083414 | Radionics Xknife HDRT System | Integra Radionics, Inc. | 2009 | — |
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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K081188 | Trilogy with External System Gating InterfaceSummary page 1…f patients immediately prior to therapy. The technological characteristics are similar to those found in the: Varian Medical Systems Trilogy Radio Therapy System 510(k) k08 1188 HDRT software is based on Integra Radionics ImageFusion 3 software (K063230) in that it compares multiple 3D images. In the case… | 2008 |
| † | K063230 | Integra Radionics Imagefusion 3 | 2006 |
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 18 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 6 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K081188.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The Radionics XKnife HDRT System is indicated for use in radiotherapy
procedures to aid in the positioning of patients immediately prior to therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083414 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083414: Radionics Xknife HDRT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083414
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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