510(k) · Cleared
ClearedPermanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 25, 2015 as substantially equivalent to K140823 (Varian Medical Systems, Inc., 2014) after a 62-day review. Its family tree reaches back 10 generations to 1987. 4 of the 33 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 25, 2015
- Review
- 62 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K874787 (1987). 32 ancestors in all. No later device cites it as a predicate yet. 4 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 6 generations between
- 3 generations backK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
- 2 generations backK123137 Calypso SystemVarian Medical Systems · 2012
- 1 generation backK140823 Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014
- This deviceK152761 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon…Varian Medical Systems, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 9 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 8 generations backK013660 GenetraRadiomed Corporation · 2001
- 7 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 6 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 5 generations backK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- 4 generations backK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- 3 generations backK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
- 2 generations backK123137 Calypso SystemVarian Medical Systems · 2012
- 1 generation backK140823 Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014
- This deviceK152761 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon…Varian Medical Systems, Inc. · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −9 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −8 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −7 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −6 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −5 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| −4 | K102373 | Calypso System with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2010 | — |
| −3 | K112768 | Calypso Systems with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2011 | — |
| −2 | K123137 | Calypso System | Varian Medical Systems | 2012 | — |
| −1 | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | Varian Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care… | Varian Medical Systems, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1996 | 2 | 1 |
| 1997 | 2 | 0 |
| 1998 | 2 | 2 |
| 1999 | 4 | 0 |
| 2000 | 2 | 1 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon TransponderSummary page 4…oduct code – IYE Classification name: Medical charged-particle radiation therapy system Predicate device: Beacon Care Package – Soft Tissue (14G) (K140823) Device Description: The Soft Tissue Beacon Transponder is a small, radiopaque, echogenic, electromagnetic fiducial marker des… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 32 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K140823.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Calypso system is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso system provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders. Implanted Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue…
Read the full statement (107 words)
The Calypso system is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso system provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.
Implanted Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.
Permanent Beacon transponders are indicated for implantation in the body, specifically in the prostate and peri-prostate tissue (i.e. prostatic bed), and in soft tissue to align and monitor the treatment isocenter in real time during radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152761: Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152761
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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