510(k) · Cleared
Recalled · Class II · 2022Photoelectric Therapy System
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 Sep 29, 2017 as substantially equivalent to K123985 (Sensus Healthcare, 2013) after an 81-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Sep 29, 2017
- Review
- 81 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962613 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK962613 Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 1996 · Recalled
- 2 generations backK063456 SRT100 Superficial Radiation Therapy SystemTopex, Inc. · 2007
- 1 generation backK123985 Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 2013
- This deviceK172080 Photoelectric Therapy SystemXstrahl, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK230611 X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962613 | Darpac 2000 Superficial X-Ray Therapy System | Gulmay Medical, Ltd. | 1996 | 2 |
| −2 | K063456 | SRT100 Superficial Radiation Therapy System | Topex, Inc. | 2007 | — |
| −1 | K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100 | Sensus Healthcare | 2013 | — |
| 0 (this device) | K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100Summary page 4…anufacturer Sensus Healthcare Device Name SRT-100 Superficial Radiation Therapy System FDA 510(k) No. K123985 Clearance given by FDA May 14th 2013 to market this device on FDA Class II FDA Product Code… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2022 | Class II | Z-1404-2022 | Finished device change control | There is a potential compatibility issue with the systems and replacement treatment applicators. |
| Apr 26, 2021 | Class II | Z-0174-2022 | Software design | If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K230611 (Xstrahl, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123985.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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/K172080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172080: Photoelectric Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172080
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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