510(k) · Cleared
ClearedSRT-100+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensus Healthcare, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Mar 23, 2018 as substantially equivalent to K150037 (Sensus Healthcare, 2015) after a 141-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Mar 23, 2018
- Review
- 141 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962613 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK962613 Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 1996 · Recalled
- 4 generations backK063456 SRT100 Superficial Radiation Therapy SystemTopex, Inc. · 2007
- 3 generations backK123985 Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 2013
- 2 generations backK131582 Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare · 2013
- 1 generation backK150037 Sensus Healthcare Superficial X-ray Radiation Therapy System with…Sensus Healthcare · 2015 · Recalled
- This deviceK173425 SRT-100+Sensus Healthcare, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962613 | Darpac 2000 Superficial X-Ray Therapy System | Gulmay Medical, Ltd. | 1996 | 2 |
| −4 | K063456 | SRT100 Superficial Radiation Therapy System | Topex, Inc. | 2007 | — |
| −3 | K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100 | Sensus Healthcare | 2013 | — |
| −2 | K131582 | Sensus Helthcare Image-Duided Superficial Radiotherapy System | Sensus Healthcare | 2013 | — |
| −1 | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic… | Sensus Healthcare | 2015 | 1 |
| 0 (this device) | K173425 | SRT-100+ | Sensus Healthcare, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging…Summary page 4…Class II Product Code: JAD Regulation Number: 892.5900 Predicate Device: Sensus Healthcare SRT-100 Vision (K150037) Reference Devices: Sensus Healthcare SRT-100 (K123985) Previous FDA Submissions & Clearances 510(k) Summar… | 2015 |
| † | K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100 | 2013 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K150037.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 SRT-100+ System is a low energy x-ray system, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include: (a) basal cell carcinoma; (b) squamous cell carcinoma; (c) Metatypic carcinoma; (d) cutaneous appendage carcinoma (e) Kaposi’s Sarcoma; and (f) the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.
A red-diode laser is employed for the assisting with cone applicator placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173425: SRT-100+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173425
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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