510(k) · Cleared
Recalled · Class II · 2023Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensus Healthcare · JAD System, Therapeutic, X-Ray
Cleared on Oct 16, 2015 as substantially equivalent to K131582 (Sensus Healthcare, 2013) after a 280-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2015
- Review
- 280 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962613 (1996). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- 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 backK131582 Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare · 2013
- This deviceK150037 Sensus Healthcare Superficial X-ray Radiation Therapy System with…Sensus Healthcare · 2015
- Descendant · cites it directly · 0 of its ownK250692 GentleBeam (GB1000)Voxel Ray Solutions, LLC · 2025
- Descendant · cites it directly · 0 of its ownK213942 EsteyaNucletron B.V. · 2022
- Descendant · cites it directly · 0 of its ownK173425 SRT-100+Sensus Healthcare, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView 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 | K131582 | Sensus Helthcare Image-Duided Superficial Radiotherapy System | Sensus Healthcare | 2013 | — |
| 0 (this device) | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic… | Sensus Healthcare | 2015 | — |
| +1 | K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 2025 | — |
| +1 | K213942 | Esteya | Nucletron B.V. | 2022 | — |
| +1 | K173425 | SRT-100+ | Sensus Healthcare, Inc. | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K131582 | Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSummary page 4…ss II Product Code: JAD Regulation Number: 892.5900 Predicate Device: Sensus Healthcare SRT-100 Vision (K131582) Section 5 – 510(k) Summary (Sensus Healthcare SRT-100 Vision) 5-1 Reference D… | 2013 |
| † | K983945 | Cortex Dermascan C Ultrasonic System | 1999 |
| † | K132092 | Esteya | 2013 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2023 | Class II | Z-1235-2023 | Software design | When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K250692 (Voxel Ray Solutions, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Vision System is a low energy x-ray system, with ultrasound imaging capability, intended for superficial radiotherapy and electronic brachytherapy 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 (¢) Kaposi’s Sarcoma; and (f) the treatment of keloids. Keloids are benign fibrous…
Read the full statement (165 words)
The SRT-100 Vision System is a low energy x-ray system, with ultrasound imaging capability, intended for superficial radiotherapy and electronic brachytherapy 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 (¢) 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.
The ultrasound capability, employed in a non-diagnostic mode, is used to assist the physician in the selection of the correct cone applicator size. The Derma-Scan C Ultrasound component was initially cleared with an indication for use as an ultrasonic scanning system used to visualize the layers of skin, including bold vessels, and to make approximate measurements of dimensions in layers of skin and blood vessels, by ultrasonic means.
The red-diode laser assembly is a commercial pointer device employed by physicians for improving the alignment of the focused beam.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150037
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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