510(k) · Cleared
ClearedStereotactic Body Frame
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instrument AB · IYE Accelerator, Linear, Medical
Cleared on Apr 23, 1996 as substantially equivalent to K934523 (Radionics, Inc., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1994. 13 later devices descend from it.
- Decided
- Apr 23, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935300 (1994). 2 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- This deviceK960338 Stereotactic Body FrameElekta Instrument AB · 1996
- Descendant · cites it directly · 9 of its ownK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
- Descendant · cites it directly · 8 of its ownK982463 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
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K970291Accessories to the Stereotactic Body FramElekta Instrument AB · 1997 · cites it directly9descendants
- K982463Extracranial Radiotherapy SystemHowmedica, Inc. · 1998 · cites it directly8descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935300 | Vac-Lok Immobilization System | Medtec, Inc. | 1994 | — |
| 0 (this device) | K960338 | Stereotactic Body Frame | Elekta Instrument AB | 1996 | — |
| +1 | K970291 | Accessories to the Stereotactic Body Fram | Elekta Instrument AB | 1997 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet…Summary page 2…phic Head Holder A by ) 193 19.4 19.5 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Radionics Gill-thomas-cosman (Gtc) K934523 2/8/95 Relocatable Head Holder S Med-Tec Vac-lok Immobilization K935300 7/18/94 System DEVICE DESCRIPTION The Stereotactic Bod… | 1995 |
| * | K935300 | Vac-Lok Immobilization SystemSummary page 2…OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Radionics Gill-thomas-cosman (Gtc) K934523 2/8/95 Relocatable Head Holder S Med-Tec Vac-lok Immobilization K935300 7/18/94 System DEVICE DESCRIPTION The Stereotactic Body Frame utilizes a reference system which is external to the patient’s bo… | 1994 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970291 | Accessories to the Stereotactic Body Fram | 1997 | 9 |
| K982463 | Extracranial Radiotherapy System | 1998 | 8 |
| K991336 | Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy | 1999 | 7 |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | 2026 | 0 |
| K031631 | Stereotactic Body Frame, Model Cod. 70-1A | 2003 | 0 |
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?
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 Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy 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/K960338 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960338: Stereotactic Body Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960338
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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