510(k) · Cleared
ClearedRotating Gamma System. Gamma Art-6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Radiosurgery, Inc. · IWB System, Radiation Therapy, Radionuclide
Cleared on Apr 6, 2006 as substantially equivalent to K970647 (Our Scientific Intl., Inc., 1997) after a 57-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Apr 6, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970647 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970647 Our Rotating Gamma SystemOur Scientific Intl., Inc. · 1997
- This deviceK060314 Rotating Gamma System. Gamma Art-6000American Radiosurgery, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK172706 GammaPod - Model AXcision Medical Systems, LLC · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK180571 GammaPodXcision Medical Systems, LLC · 2018 · Recalled
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 |
|---|---|---|---|---|---|
| −1 | K970647 | Our Rotating Gamma System | Our Scientific Intl., Inc. | 1997 | — |
| 0 (this device) | K060314 | Rotating Gamma System. Gamma Art-6000 | American Radiosurgery, Inc. | 2006 | — |
| +1 | K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017 | 1 |
| +2 | K180571 | GammaPod | Xcision Medical Systems, LLC | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K970647 | Our Rotating Gamma SystemSummary page 1…herapy System Classification name: Radionuclide Radiation Therapy System Substantial equivalence claimed to: Predicate 5 10(k) Number K970647 Description: This 510(k) Special Submission if for a modification to cleared K970647 Rotating Gamma System that has received a m… | 1997 |
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 |
|---|---|---|---|
| K172706 | GammaPod - Model A | 2017 | 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?
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 Rotating Gamma System, GammaART 6000 is a tele-therapy radiation treatment device intended to be used for stereotactic irradiation of intracranial structures. The device is to be used by licensed medical professionals, having been trained in the use and safety precautions of this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060314: Rotating Gamma System. Gamma Art-6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060314
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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