510(k) · Cleared
ClearedOur Rotating Gamma System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Our Scientific Intl., Inc. · IWB System, Radiation Therapy, Radionuclide
Cleared on May 20, 1997 after an 89-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- May 20, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK970647 Our Rotating Gamma SystemOur Scientific Intl., Inc. · 1997
- Descendant · cites it directly · 3 of its ownK190844 Akesis GalaxyAkesis, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK200050 Akesis Galaxy RTxAkesis, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK060314 Rotating Gamma System. Gamma Art-6000American Radiosurgery, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK172706 GammaPod - Model AXcision Medical Systems, LLC · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK203250 TaiChiCOur United Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190844Akesis GalaxyAkesis, Inc. · 2019 · cites it directly3descendants
- K200050Akesis Galaxy RTxAkesis, Inc. · 2020 · 2 generations on2descendants
- K060314Rotating Gamma System. Gamma Art-6000American Radiosurgery, Inc. · 2006 · cites it directly2descendants
- K172706GammaPod - Model AXcision Medical Systems, LLC · 2017 · 2 generations on1descendant
- K203250TaiChiCOur United Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970647 | Our Rotating Gamma System | Our Scientific Intl., Inc. | 1997 | — |
| +1 | K190844 | Akesis Galaxy | Akesis, Inc. | 2019 | — |
| +2 | K200050 | Akesis Galaxy RTx | Akesis, Inc. | 2020 | — |
| +1 | K060314 | Rotating Gamma System. Gamma Art-6000 | American Radiosurgery, Inc. | 2006 | — |
| +2 | K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017 | 1 |
| +3 | K203250 | TaiChiC | Our United Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | — | Leksell Gamma Unit Model 23004, Type B Named without a submission number |
What descends from it? (7)
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, K190844 (Akesis, Inc., 2019) has gone furthest, with 3 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.
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 OUR Rotatifig” Gamma System is a teletherapy device intended to be used for the stereotactic irradiation of intracranial structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970647 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970647: Our Rotating Gamma System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970647
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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