510(k) · Cleared
ClearedRotating Gamma System Infini (Infini)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masep Medical Science & Tech.Development (Shenzhen · IWB System, Radiation Therapy, Radionuclide
Cleared on Mar 22, 2011 as substantially equivalent to K041125 (Masep Med Science & Tech. Development (Shenzhen) C, 2004) and 1 other predicate after a 200-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Mar 22, 2011
- Review
- 200 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K924849 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- 2 generations backK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999 · Recalled
- 1 generation backK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- This deviceK102533 Rotating Gamma System Infini (Infini)Masep Medical Science & Tech.Development (Shenzhen · 2011
- Descendant · cites it directly · 0 of its ownK131777 Hyper Source-Unit Rotating Gamma SystemHyper Technology, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K131777Hyper Source-Unit Rotating Gamma SystemHyper Technology, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| −2 | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | 4 |
| −1 | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| 0 (this device) | K102533 | Rotating Gamma System Infini (Infini) | Masep Medical Science & Tech.Development (Shenzhen | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K041125 | Masep SRRS Gamma Rays Stereotactic Radiation Therapy System for Heads (Masep Gamma…Summary page 2…arison with MASEP Predicate Device: The Rotating Gamma System Infmni TM is an improvement of the MASEP Gamma Therapy System for which MASEP was cleared under K(041125. All safety and effectiveness testing (including risk analysis and pertinent performance testing) were conducted and complet… | 2004 |
| * | K061941 | Leksell Gamma Knife Perfexion, Model 715000Summary page 1…MASEP Medical Science & Technology Development (Shenzhen) Co., Ltd. and the Leksell Gamma Knife®0 PerfexionTM (K#061941), manufactured and marketed by Elekta Instruments AH for treating… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131777 | Hyper Source-Unit Rotating Gamma System | 2014 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K131777 (Hyper Technology, Inc., 2014) has gone furthest, with 0 descendants 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. 2011, 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 Rotating Gamma System InfiniTM (InfiniTM) 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/K102533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102533: Rotating Gamma System Infini (Infini).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102533
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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