510(k) · Cleared
ClearedExplorer 4D Treatment Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Radiosurgery, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Nov 5, 2010 as substantially equivalent to K093588 (American Radiosurgery, Inc., 2010) after a 186-day review. Its family tree reaches back 1 generation to 2010. 2 later devices descend from it.
- Decided
- Nov 5, 2010
- Review
- 186 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093588 (2010). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK093588 Explorer 4D Treatment Planning SystemAmerican Radiosurgery, Inc. · 2010
- This deviceK101220 Explorer 4D Treatment Planning SystemAmerican Radiosurgery, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK193459 Panther StereotacticProwess, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK231825 Panther TPSProwess, Inc. · 2023
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 | K093588 | Explorer 4D Treatment Planning System | American Radiosurgery, Inc. | 2010 | — |
| 0 (this device) | K101220 | Explorer 4D Treatment Planning System | American Radiosurgery, Inc. | 2010 | — |
| +1 | K193459 | Panther Stereotactic | Prowess, Inc. | 2020 | — |
| +2 | K231825 | Panther TPS | Prowess, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K093588 | Explorer 4D Treatment Planning SystemSummary page 2…rsion 2.1 of the Explorer 4D TmTreatment Planning System include the capability to prepare treatment plans using MR images as well as CT images cleared under submission K093588 (version 2.0). Functional testing has demonstrated that version 2.1 is safe and effective and accuracy comparison tests have demo… | 2010 |
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 |
|---|---|---|---|
| K193459 | Panther Stereotactic | 2020 | 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?
- Its one ancestor has no recall.
- Of its descendants, K193459 (Prowess, Inc., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The Explorer 4D Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed.
The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101220: Explorer 4D Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101220
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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