510(k) · Cleared
ClearedBeamSite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doseoptics, LLC · IYE Accelerator, Linear, Medical
Cleared on Sep 15, 2021 as substantially equivalent to K200940 (Doseoptics, LLC, 2020) after a 29-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Sep 15, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901932 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK901932 Varian Electronic Portal Imaging SystemVarian Assoc., Inc. · 1991
- 3 generations backK971839 Varian Radiation Therapy Imaging SystemVarian Medical Systems, Inc. · 1997
- 2 generations backK091209 Portalvision Advanced ImagingVarian Medical Systems, Inc. · 2009 · Recalled
- 1 generation backK200940 BeamSiteDoseoptics, LLC · 2020
- This deviceK212606 BeamSiteDoseoptics, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901932 | Varian Electronic Portal Imaging System | Varian Assoc., Inc. | 1991 | — |
| −3 | K971839 | Varian Radiation Therapy Imaging System | Varian Medical Systems, Inc. | 1997 | — |
| −2 | K091209 | Portalvision Advanced Imaging | Varian Medical Systems, Inc. | 2009 | 1 |
| −1 | K200940 | BeamSite | Doseoptics, LLC | 2020 | — |
| 0 (this device) | K212606 | BeamSite | Doseoptics, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K200940 | BeamSiteSummary page 4…ass: II Product Code: IYE Panel: Radiology 5.3. PREDICATE DEVICE BeamSite System, K200940 manufactured by DoseOptics LLC. 5.4. DEVICE DESCRIPTION BeamSite™ is a camera system that enables live visualiza… | 2020 |
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 30 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212606: BeamSite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212606
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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