510(k) · Cleared
ClearedHyper Source-Unit Rotating Gamma System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyper Technology, Inc. · IWB System, Radiation Therapy, Radionuclide
Cleared on Feb 28, 2014 as substantially equivalent to K102533 (Masep Medical Science & Tech.Development (Shenzhen, 2011) after a 256-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 28, 2014
- Review
- 256 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924849 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- 3 generations backK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999 · Recalled
- 2 generations backK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- 1 generation backK102533 Rotating Gamma System Infini (Infini)Masep Medical Science & Tech.Development (Shenzhen · 2011
- This deviceK131777 Hyper Source-Unit Rotating Gamma SystemHyper Technology, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| −3 | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | 4 |
| −2 | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| −1 | K102533 | Rotating Gamma System Infini (Infini) | Masep Medical Science & Tech.Development (Shenzhen | 2011 | — |
| 0 (this device) | K131777 | Hyper Source-Unit Rotating Gamma System | Hyper Technology, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K102533 | Rotating Gamma System Infini (Infini)Summary page 2…l+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures. 5. Predicate Device Identification 510(k) Number: K 102533 Predicate Device Name:Rotating Gamma System lnfiniTM1 Manufacturer: Measep Infini Medical Science Technology Developm… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Hyper Source-unit Rotating Gamma System (SGS-I+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131777: Hyper Source-Unit Rotating Gamma System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131777
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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