510(k) · Cleared
ClearedXknife-3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics Software Applications, Inc. · IYE Accelerator, Linear, Medical
Cleared on Oct 25, 1995 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 25, 1995
- Review
- 93 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK953482 Xknife-3Radionics Software Applications, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK973936 Focus RTP SystemComputerized Medical Systems, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK090182 Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009
- Descendant · cites it directly · 0 of its ownK974310 Nomos Slit Collimator (Beak)Nomos Corp. · 1998
- Descendant · cites it directly · 0 of its ownK972816 Advanced Treatment Planning SystemAdvanced Radiation Therapy Systems, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K973936Focus RTP SystemComputerized Medical Systems, Inc. · 1998 · cites it directly1descendant
- K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009 · 2 generations on0descendants
- K974310Nomos Slit Collimator (Beak)Nomos Corp. · 1998 · cites it directly0descendants
- K972816Advanced Treatment Planning SystemAdvanced Radiation Therapy Systems, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953482 | Xknife-3 | Radionics Software Applications, Inc. | 1995 | — |
| +1 | K973936 | Focus RTP System | Computerized Medical Systems, Inc. | 1998 | — |
| +2 | K090182 | Module Integrated Radiotherapy System (Mirs) | Nuclemed S.A. | 2009 | — |
| +1 | K974310 | Nomos Slit Collimator (Beak) | Nomos Corp. | 1998 | — |
| +1 | K972816 | Advanced Treatment Planning System | Advanced Radiation Therapy Systems, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 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, K973936 (Computerized Medical Systems, Inc., 1998) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K953482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953482: Xknife-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953482
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026