510(k) · Cleared
ClearedMasep SRRS Gamma Rays Stereotactic Radiation Therapy System for Heads (Masep Gamma Therapy System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masep Med Science & Tech. Development (Shenzhen) C · IWB System, Radiation Therapy, Radionuclide
Cleared on Dec 30, 2004 after a 244-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Dec 30, 2004
- Review
- 244 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK041125 Masep SRRS Gamma Rays Stereotactic Radiation Therapy System for…Masep Med Science & Tech. Development (Shenzhen) C · 2004
- Descendant · cites it directly · 1 of its ownK102533 Rotating Gamma System Infini (Infini)Masep Medical Science & Tech.Development (Shenzhen · 2011
- Descendant · 2 generations on · 0 of its ownK131777 Hyper Source-Unit Rotating Gamma SystemHyper Technology, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041125 | Masep SRRS Gamma Rays Stereotactic Radiation Therapy System for Heads (Masep… | Masep Med Science & Tech. Development (Shenzhen) C | 2004 | — |
| +1 | K102533 | Rotating Gamma System Infini (Infini) | Masep Medical Science & Tech.Development (Shenzhen | 2011 | — |
| +2 | K131777 | Hyper Source-Unit Rotating Gamma System | Hyper Technology, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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 IWB? 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 IWB device
- #1 K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell…score 11.2 · 13 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102533 | Rotating Gamma System Infini (Infini) | 2011 | 1 |
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, K102533 (Masep Medical Science & Tech.Development (Shenzhen, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IWB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IWB
57in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IWB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWB
3in 2025
MAUDE reports naming product code IWB, 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 | — | 3 | 8 |
| 2008 | 0 | — | 3 | 15 |
| 2009 | 1 | — | 1 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 3 | 170 | 1 | 8 |
| 2015 | 3 | 79 | 0 | 5 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 57 | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K041125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041125: Masep SRRS Gamma Rays Stereotactic Radiation Therapy System for Heads (Masep Gamma 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/K041125
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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