510(k) · Cleared
ClearedX80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xstrahl, Ltd. · JAD System, Therapeutic, X-Ray
Cleared on Jul 13, 2023 as substantially equivalent to K172080 (Xstrahl, Ltd., 2017) after a 129-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jul 13, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962613 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK962613 Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 1996 · Recalled
- 3 generations backK063456 SRT100 Superficial Radiation Therapy SystemTopex, Inc. · 2007
- 2 generations backK123985 Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 2013
- 1 generation backK172080 Photoelectric Therapy SystemXstrahl, Ltd. · 2017 · Recalled
- This deviceK230611 X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962613 | Darpac 2000 Superficial X-Ray Therapy System | Gulmay Medical, Ltd. | 1996 | 2 |
| −3 | K063456 | SRT100 Superficial Radiation Therapy System | Topex, Inc. | 2007 | — |
| −2 | K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100 | Sensus Healthcare | 2013 | — |
| −1 | K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | 2017 | 2 |
| 0 (this device) | K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K172080 | Photoelectric Therapy SystemSummary page 5…iology Product Code: JAD Regulation Number: 21CFR 892.5900 G. PREDICATE DEVICES: X80 / RADiant / PhotoElectric Therapy System (K172080) H. STATEMENT ON INDICATIONS FOR USE: The intended use and indications for use of the system have not changed due to the modi… | 2017 |
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 27 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.
Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230611: X80 / RADiant / PhotoElectric Therapy System (RADiant Aura).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230611
Report an extraction error
Are you the manufacturer?
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