510(k) · Cleared
Recalled · Class II · 2023GammaPod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xcision Medical Systems, LLC · IWB System, Radiation Therapy, Radionuclide
Cleared on Apr 4, 2018 as substantially equivalent to K172706 (Xcision Medical Systems, LLC, 2017) after a 30-day review. Its family tree reaches back 3 generations to 1997. It has been recalled 2 times.
- Decided
- Apr 4, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970647 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK970647 Our Rotating Gamma SystemOur Scientific Intl., Inc. · 1997
- 2 generations backK060314 Rotating Gamma System. Gamma Art-6000American Radiosurgery, Inc. · 2006
- 1 generation backK172706 GammaPod - Model AXcision Medical Systems, LLC · 2017 · Recalled
- This deviceK180571 GammaPodXcision Medical Systems, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970647 | Our Rotating Gamma System | Our Scientific Intl., Inc. | 1997 | — |
| −2 | K060314 | Rotating Gamma System. Gamma Art-6000 | American Radiosurgery, Inc. | 2006 | — |
| −1 | K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017 | 1 |
| 0 (this device) | K180571 | GammaPod | Xcision Medical Systems, LLC | 2018 | — |
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 |
|---|---|---|---|
| * | K172706 | GammaPod - Model ASummary page 4…IWB Device Classification: 21 CFR 892.5750, Class II III. PREDICATE DEVICE IDENTIFICATION Predicate Device: GammaPod (K172706) IV. DEVICE DESCRIPTION The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamm… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2023 | Class II | Z-0750-2024 | Software design | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected |
| Jul 3, 2019 | Class II | Z-2081-2019 | Nonconforming Material/Component | One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 3 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. 2018, 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?
GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
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/K180571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180571: GammaPod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180571
Report an extraction error
Are you the manufacturer?
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