510(k) · Cleared
ClearedExtracranial Radiotherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · IYE Accelerator, Linear, Medical
Cleared on Sep 30, 1998 as substantially equivalent to K960338 (Elekta Instrument AB, 1996) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1994. 8 later devices descend from it.
- Decided
- Sep 30, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K935300 (1994). 6 ancestors in all, the oldest K854886 (1986). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- 1 generation backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
- This deviceK982463 Extracranial Radiotherapy SystemHowmedica, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999
- Descendant · 2 generations on · 6 of its ownK100691 Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010
- Descendant · 3 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- Descendant · 4 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- Descendant · 5 generations on · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999 · cites it directly7descendants
- K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010 · 2 generations on6descendants
- K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 3 generations on5descendants
- K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 4 generations on3descendants
- K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935300 | Vac-Lok Immobilization System | Medtec, Inc. | 1994 | — |
| −1 | K960338 | Stereotactic Body Frame | Elekta Instrument AB | 1996 | — |
| 0 (this device) | K982463 | Extracranial Radiotherapy System | Howmedica, Inc. | 1998 | — |
| +1 | K991336 | Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy | Medical Instrumentation & Diagnostics Corp.(Midco) | 1999 | — |
| +2 | K100691 | Omni V SBRT Positioning System, Model RT-4500 | Bionix Development Corp. | 2010 | — |
| +3 | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
| +4 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body… | Medtec, Inc. D/B/A Civco Medical Solutions | 2016 | — |
| +5 | K210894 | Siddharth-II; Impact | Panacea Medical Technologies Pvt., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960338 | Stereotactic Body FrameSummary page 1…e Leibinger software planning systems. The subject device is substantially equivalent to the following devices: Stereotactic Body Frame (Precision Therapy International K960338, K370291), STP Complete Module/ZD Stereotaxic Frame (Leibinger K892425/D), and Marker System for Stereotaxic Navigation (Leibinge… | 1996 |
| Kept off the family tree | K370291 | Stereotactic Body Frame Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…er software planning systems. The subject device is substantially equivalent to the following devices: Stereotactic Body Frame (Precision Therapy International K960338, K370291), STP Complete Module/ZD Stereotaxic Frame (Leibinger K892425/D), and Marker System for Stereotaxic Navigation (Leibinger K961120… | |
| * | K892425 | STP Complete Module SetSummary page 1…ioning and localization during imaging and treatment of extracranial targets. The table is design to be used with Leibinger's STP Complete Module Set and Marker System (K892425) and any future Leibinger software planning systems. The subject device is substantially equivalent to the following devices: St… | 1990 |
| * | K961120 | Marker System for Stereotaxic NavigationSummary page 1…recision Therapy International K960338, K370291), STP Complete Module/ZD Stereotaxic Frame (Leibinger K892425/D), and Marker System for Stereotaxic Navigation (Leibinger K961120). The Extracranial Radiosurgery System and the Stereotactic Body Frame are equivalent in intended use and in design in that they… | 1996 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991336 | Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy | 1999 | 7 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K991336 (Medical Instrumentation & Diagnostics Corp.(Midco), 1999) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K960338.
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?
The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.
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/K982463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982463: Extracranial Radiotherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982463
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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