510(k) · Cleared
ClearedInterlocked Circular Small Field Collimators, Elekta Integrated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aktina Medical Corporation · IYE Accelerator, Linear, Medical
Cleared on Sep 27, 2016 as substantially equivalent to K123788 (Varian Medical Systems, Inc., 2013) after a 70-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Sep 27, 2016
- Review
- 70 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971893 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK971893 SNT Linac AccessoriesSurgical Navigation Technologies, Inc. · 1997
- 1 generation backK123788 Integrated Collimator Verification and Interlock System (Icvi)Varian Medical Systems, Inc. · 2013
- This deviceK161984 Interlocked Circular Small Field Collimators, Elekta IntegratedAktina Medical Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971893 | SNT Linac Accessories | Surgical Navigation Technologies, Inc. | 1997 | — |
| −1 | K123788 | Integrated Collimator Verification and Interlock System (Icvi) | Varian Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K161984 | Interlocked Circular Small Field Collimators, Elekta Integrated | Aktina Medical Corporation | 2016 | — |
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 |
|---|---|---|---|
| * | K123788 | Integrated Collimator Verification and Interlock System (Icvi)Summary page 4…icle radiation therapy system.” The product code is IYE. 5. Predicate Device Integrated Conical Collimator Verification and Interlock system (ICVI), 510(k) No. K123788, Varian Medical Systems, 3100 Hansen Way, Palo Alto, CA 94304 USA 6. Description This is a Traditional 510(k) that… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Circular Small Field Collimators, Elekta Integrated, are intended for use with the Elekta line of digital medical linear
accelerators (LINAC) for the creation of small circular fields. These fields are used for patients who require external beam
radiation therapy or stereotactic radiosurgery of the cranial or extra cranial regions for the treatment of tumors or lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161984: Interlocked Circular Small Field Collimators, Elekta Integrated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161984
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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