510(k) · Cleared
ClearedAccessories to the Stereotactic Body Fram
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 24, 1997 as substantially equivalent to K960338 (Elekta Instrument AB, 1996) after a 90-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Apr 24, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935300 (1994). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- 1 generation backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
- This deviceK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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) | K970291 | Accessories to the Stereotactic Body Fram | Elekta Instrument AB | 1997 | — |
| +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 |
|---|---|---|
| 1995 | 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 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K960338 | Stereotactic Body FrameSummary page 1…l charged-particle radiation therapy system 173 IDENTIFICATION OF PREDICATE DEVICE Company Device S100) No. Date Cleared Elekta Instrument AB Stereotactic Body Frame K960338 April 23, 1996 174 DEVICE DESCRIPTION The Stereotactic Body Frame utilizes a reference system of coordinates that can be reprod… | 1996 |
What descends from it? (9)
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- 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 Accessories to the Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extra cranial 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/K970291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970291: Accessories to the Stereotactic Body Fram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970291
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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