510(k) · Cleared
ClearedSRT100 Superficial Radiation Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topex, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Jan 9, 2007 as substantially equivalent to K971074 (Pantak, Inc., 1997) and 1 other predicate after a 55-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Jan 9, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962613 (1996). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK962613 Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 1996 · Recalled
- This deviceK063456 SRT100 Superficial Radiation Therapy SystemTopex, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK123985 Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 2013
- Descendant · 2 generations on · 4 of its ownK131582 Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare · 2013
- Descendant · 3 generations on · 3 of its ownK150037 Sensus Healthcare Superficial X-ray Radiation Therapy System with…Sensus Healthcare · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK172080 Photoelectric Therapy SystemXstrahl, Ltd. · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK132092 EsteyaNucletron B.V. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K123985Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 2013 · cites it directly7descendants
- K131582Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare · 2013 · 2 generations on4descendants
- K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging…Sensus Healthcare · 2015 · 3 generations on3descendants
- K172080Photoelectric Therapy SystemXstrahl, Ltd. · 2017 · 2 generations on1descendant
- K132092EsteyaNucletron B.V. · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962613 | Darpac 2000 Superficial X-Ray Therapy System | Gulmay Medical, Ltd. | 1996 | 2 |
| 0 (this device) | K063456 | SRT100 Superficial Radiation Therapy System | Topex, Inc. | 2007 | — |
| +1 | K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100 | Sensus Healthcare | 2013 | — |
| +2 | K131582 | Sensus Helthcare Image-Duided Superficial Radiotherapy System | Sensus Healthcare | 2013 | — |
| +3 | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic… | Sensus Healthcare | 2015 | 1 |
| +2 | K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | 2017 | 2 |
| +1 | K132092 | Esteya | Nucletron B.V. | 2013 | — |
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 |
|---|---|---|
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K971074 | Therapax SXT 150Summary page 1…essories Product Code: JAD CFR Classification: 892.5900 5.3 Predicate Devices Pantak Superficial X-ray Therapy System (K971074) Gulmay D3100/Xstrahl 100 (K962613) Philips RT100 (pre-1976 Amendments device) 5.4 Indications… | 1997 |
| * | K962613 | Darpac 2000 Superficial X-Ray Therapy SystemSummary page 1…CFR Classification: 892.5900 5.3 Predicate Devices Pantak Superficial X-ray Therapy System (K971074) Gulmay D3100/Xstrahl 100 (K962613) Philips RT100 (pre-1976 Amendments device) 5.4 Indications for Use The SRT100 is a low energy x-ray system inte… | 1996 |
| * | — | Philips RT100 Named without a submission number |
What descends from it? (9)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 is a low energy x-ray system intended for superficial radiotherapy treatment of primary malignant epithelial neoplasms of the skin. Typical applications include basal cell carcinoma, squamous cell carcinoma, Metatypic carcinoma, cutaneous appendage carcinoma and Kaposi's Sarcoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063456 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063456: SRT100 Superficial Radiation Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063456
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