510(k) · Cleared
ClearedAxxent Radiation Shield - Rigid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xoft, an Icad Company · JAD System, Therapeutic, X-Ray
Cleared on Jul 20, 2011 as substantially equivalent to K992577 (Photoelectron Corporation, 1999) after a 72-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jul 20, 2011
- Review
- 72 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). 7 ancestors in all, the oldest K852907 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 1 generation backK992577 Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999
- This deviceK111299 Axxent Radiation Shield - RigidXoft, an Icad Company · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −2 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −1 | K992577 | Photon Radiosurgery System (PRS) | Photoelectron Corporation | 1999 | — |
| 0 (this device) | K111299 | Axxent Radiation Shield - Rigid | Xoft, an Icad Company | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K992577 | Photon Radiosurgery System (PRS)Summary page 1…___ __ ___ ___ ___ ___ __ ___ ___ __ ___ ___ __ K992577 Axxent® Radiation Shield - Rigid 510(k) Xoff, an iCAD Company… | 1999 |
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 25 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 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. 2011, 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?
Use of the Axxent Radiation Shield - Rigid is indicated in cases in which protection of tissue and/or organs from x-radiation is desired. The Axxent Radiation Shield - Rigid can be used externally and internally, such as during intraoperative radiation therapy (JORT) when the treatment site is exposed surgically.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111299: Axxent Radiation Shield - Rigid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111299
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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