510(k) · Cleared
ClearedXPLAN-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics Software Applications, Inc. · IYE Accelerator, Linear, Medical
Cleared on Oct 28, 1997 after an 83-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Oct 28, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK972905 XPLAN-1Radionics Software Applications, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK991237 Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 1 of its ownK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
- Descendant · 3 generations on · 0 of its ownK103616 Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011
- Descendant · cites it directly · 0 of its ownK981597 Radionics Slice Editor Imaging Software UtilityRadionics, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K991237Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc. · 1999 · cites it directly2descendants
- K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008 · 2 generations on1descendant
- K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011 · 3 generations on0descendants
- K981597Radionics Slice Editor Imaging Software UtilityRadionics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972905 | XPLAN-1 | Radionics Software Applications, Inc. | 1997 | — |
| +1 | K991237 | Xplan-2 with Head and Neck Localizer, Model HNL | Radionics, Inc. | 1999 | 1 |
| +2 | K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | Aktina Medical Physics Corp. | 2008 | — |
| +3 | K103616 | Pinpoint Stereotactic Head and Neck Localizer | Aktina Medical Physics Corp. | 2011 | — |
| +1 | K981597 | Radionics Slice Editor Imaging Software Utility | Radionics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | RSA XKnife-3 System Named without a submission number | |
| * | — | CMS Focus System Named without a submission number |
What descends from it? (4)
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, K991237 (Radionics, Inc., 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
XPlan-1 is a stereotactic LINAC-based radiation treatment planning system. XPlan-1 localizes lesions to be treated using CT scans, MR scans and digitized angiographic film. XPlan-1 provides a stereotactic planning system, for treatment of tumors < 7 cm in diameter at sites such as cranial, base of skull and head. 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/K972905 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972905: XPLAN-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972905
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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