510(k) · Decided
DecidedAxxent Electronic Brachytherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xoft, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Dec 22, 2005 as substantially equivalent to K992577 (Photoelectron Corporation, 1999) and 4 other predicates after a 265-day review. Its family tree reaches back 6 generations to 1986. 8 later devices descend from it.
- Decided
- Dec 22, 2005
- Review
- 265 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K864210 (1986). 14 ancestors in all, the oldest K852907 (1985). 8 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 5 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 4 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 3 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 2 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 1 generation backK032067 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- This deviceK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK153570 Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK132092 EsteyaNucletron B.V. · 2013
- Descendant · cites it directly · 1 of its ownK090914 Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E…Xoft, Inc. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072683Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008 · cites it directly5descendants
- K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013 · 2 generations on4descendants
- K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016 · 3 generations on1descendant
- K132092EsteyaNucletron B.V. · 2013 · 3 generations on1descendant
- K090914Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067EXoft, Inc. · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −5 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −4 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −3 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −2 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −1 | K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| 0 (this device) | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
| +1 | K072683 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2008 | — |
| +2 | K122951 | Xoft Axxent Electronic Brachytherapy System Model 110 | Icad, Inc. | 2013 | — |
| +3 | K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | 2016 | — |
| +3 | K132092 | Esteya | Nucletron B.V. | 2013 | — |
| +1 | K090914 | Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E | Xoft, Inc. | 2009 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K992577 | Photon Radiosurgery System (PRS)Summary page 1…Premarket Notification (Date) Photoelectron Corporation Photon Radiosurgery K992577 System (PRS) and Spherical Applicators . 09/23/1999)___ Varian VariSource Remote Afterloader… | 1999 |
| * | K945383 | High Dose Rate AfterloaderSummary page 1…ery K992577 System (PRS) and Spherical Applicators . 09/23/1999)___ Varian VariSource Remote Afterloader K945383 (02/15/1995) Proxima Therapeutics MammoSite Radiation… | 1995 |
| * | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TraySummary page 1…K945383 (02/15/1995) Proxima Therapeutics MammoSite Radiation K011690 Therapy System (RTS) (05/06/2002) Proxima Therapeutics MammoSite Radiation… | 2002 |
| * | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TraySummary page 1…n K011690 Therapy System (RTS) (05/06/2002) Proxima Therapeutics MammoSite Radiation K030558 Therapy System (RTS) (05/21/2003) Proxima Therapeutics MammoSite Radiation… | 2003 |
| * | K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TraySummary page 1…n K030558 Therapy System (RTS) (05/21/2003) Proxima Therapeutics MammoSite Radiation K032067 Therapy System (RTS) (02/10/2004) C. Device description The three components of th… | 2004 |
What descends from it? (8)
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 19 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K072683 (Xoft, Inc., 2008) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K992577.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
The safety and effectiveness of the Axxent Electronic Brachytherapy System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050843 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050843: Axxent Electronic Brachytherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050843
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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