510(k) · Cleared
Recalled · 2004Xplan-2 with Head and Neck Localizer, Model HNL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Aug 30, 1999 as substantially equivalent to K972905 (Radionics Software Applications, Inc., 1997) and 3 other predicates after a 140-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 30, 1999
- Review
- 140 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K934523 (1995). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK934523 Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc. · 1995
- 1 generation backK962155 Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996
- This deviceK991237 Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
- Descendant · 2 generations on · 0 of its ownK103616 Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011
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 |
|---|---|---|---|---|---|
| −2 | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth… | Radionics, Inc. | 1995 | — |
| −1 | K962155 | Gill-Thomas-Cosman (GTC) Dental Tray | Radionics Software Applications, Inc. | 1996 | — |
| 0 (this device) | K991237 | Xplan-2 with Head and Neck Localizer, Model HNL | Radionics, Inc. | 1999 | — |
| +1 | K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | Aktina Medical Physics Corp. | 2008 | — |
| +2 | K103616 | Pinpoint Stereotactic Head and Neck Localizer | Aktina Medical Physics Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 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? (4)
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 |
|---|---|---|---|
| * | K972905 | XPLAN-1Summary page 1…tantially equivalent to the following medical devices: e XPlan-1 LINAC-based Radiation Treatment Planning System, Manufactured by Radionics Software Applications, Inc., K972905. e XKnife-4 LINAC-based Radiosurgery and Radiotherapy Treatment Planning System, Manufactured by Radionics Software Applications… | 1997 |
| * | K981055 | Xknife-4Summary page 1…ware Applications, Inc., K972905. e XKnife-4 LINAC-based Radiosurgery and Radiotherapy Treatment Planning System, Manufactured by Radionics Software Applications, Inc., K981055. Radionics Software Applications, Inc. 4/7/99 CONFIDENTIAL XPlan-2 510¢k) ' Appendix G Page 1 Radionics Software… | 1998 |
| * | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet…Summary page 2…ntially equivalent to the following medical devices: ‘ e Gill-Thomas-Cosman (GTC) Relocatable Head Holder System, Manufactured by Radionics Software Applications, Inc., K934523 and K962155. e Laser Angio Target Localizer (LATL), Manufactured by Radionics Software Applications, Inc., K972905. 4, DEVICE D… | 1995 |
| * | K962155 | Gill-Thomas-Cosman (GTC) Dental TraySummary page 2…valent to the following medical devices: ‘ e Gill-Thomas-Cosman (GTC) Relocatable Head Holder System, Manufactured by Radionics Software Applications, Inc., K934523 and K962155. e Laser Angio Target Localizer (LATL), Manufactured by Radionics Software Applications, Inc., K972905. 4, DEVICE DESCRIPTION… | 1996 |
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 |
|---|---|---|---|
| K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2004 | Not classified | Z-1020-04 | Other | Software may provide inaccurate coordinates and cause mistreatment |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081935 (Aktina Medical Physics Corp., 2008) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K972905.
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.
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?
XPlan-2 is a stereotactic LINAC-based radiation treatment planning system. XPlan-2 localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan-2 provides a stereotactic planning system for treatment of tumors at sites such as cranial, base of skull, head and neck. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
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/K991237 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991237: Xplan-2 with Head and Neck Localizer, Model HNL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991237
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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