510(k) · Cleared
ClearedXoft Axxent Electronic Brachytherapy System Model 110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icad, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Jan 17, 2013 as substantially equivalent to K072683 (Xoft, Inc., 2008) and 1 other predicate after a 114-day review. Its family tree reaches back 8 generations to 1986. 4 later devices descend from it.
- Decided
- Jan 17, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K864210 (1986). 17 ancestors in all, the oldest K852907 (1985). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 7 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 6 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 5 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 4 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 3 generations backK032067 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 2 generations backK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- 1 generation backK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
- This deviceK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK153570 Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK132092 EsteyaNucletron B.V. · 2013
- Descendant · 2 generations on · 0 of its ownK213942 EsteyaNucletron B.V. · 2022
- Descendant · 2 generations on · 0 of its ownK182641 Sensus IORT SystemSensus Healthcare, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016 · cites it directly1descendant
- K132092EsteyaNucletron B.V. · 2013 · cites it directly1descendant
- K213942EsteyaNucletron B.V. · 2022 · 2 generations on0descendants
- K182641Sensus IORT SystemSensus Healthcare, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −7 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −6 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −5 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −4 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −3 | K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −2 | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
| −1 | K072683 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2008 | — |
| 0 (this device) | K122951 | Xoft Axxent Electronic Brachytherapy System Model 110 | Icad, Inc. | 2013 | — |
| +1 | K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | 2016 | — |
| +1 | K132092 | Esteya | Nucletron B.V. | 2013 | — |
| +2 | K213942 | Esteya | Nucletron B.V. | 2022 | — |
| +2 | K182641 | Sensus IORT System | Sensus Healthcare, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 JAD? 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 JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K072683 | Axxent Electronic Brachytherapy SystemSummary page 2…Concurrence Reference fi Date Axxent Electronic Brachytherapy Xoft K072683 2/29/08 System Variource 200 HDR Afterloader Varian K061582 7/2… | 2008 |
| * | K061582 | Varisource 200 HDR AfterloaderSummary page 2…Electronic Brachytherapy Xoft K072683 2/29/08 System Variource 200 HDR Afterloader Varian K061582 7/25/06 Device Description The Axxent Electronic Brachytherapy System consists of three primary components: the Ax… | 2006 |
What descends from it? (4)
2 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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K153570 (Icad, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Axxent® Electronic Brachytherapy System is a high dose rate brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122951: Xoft Axxent Electronic Brachytherapy System Model 110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122951
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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