510(k) · Cleared
Recalled · Class II · 2021Darpac 2000 Superficial X-Ray Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gulmay Medical, Ltd. · JAD System, Therapeutic, X-Ray
Cleared on Sep 27, 1996 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 27, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK962613 Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 1996
- 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) | K962613 | Darpac 2000 Superficial X-Ray Therapy System | Gulmay Medical, Ltd. | 1996 | — |
| +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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 27, 2021 | Class II | Z-0389-2022 | Device Design | Base plate may detach from the main body of the treatment applicator. |
| 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?
- 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 | — |
https://510kreport.com/device/K962613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962613: Darpac 2000 Superficial X-Ray 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/K962613
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026