510(k) · Cleared
ClearedTherapax SXT 150
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pantak, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Jun 13, 1997 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Jun 13, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK971074 Therapax SXT 150Pantak, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK063456 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K063456SRT100 Superficial Radiation Therapy SystemTopex, Inc. · 2007 · cites it directly9descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971074 | Therapax SXT 150 | Pantak, Inc. | 1997 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
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?
- Of its descendants, K063456 (Topex, Inc., 2007) has gone furthest, with 9 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.
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 Therapax SXT 150 is a variable low energy x-ray system intended for superficial
radiotherapy treatments of cancerous tumors and lesions. Typical applications include
treatment for basal cell carcinoma, squamous cell carcinoma, Karposi’s Sarcoma, rectal
adenocarcinoma and other intracavital sites.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971074: Therapax SXT 150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971074
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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