510(k) · Cleared
ClearedCalypso System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · IYE Accelerator, Linear, Medical
Cleared on Dec 5, 2012 as substantially equivalent to K060906 (Calypso Medical Technologies, Inc., 2006) and 2 other predicates after a 61-day review. Its family tree reaches back 8 generations to 1987. 4 of the 31 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Dec 5, 2012
- Review
- 61 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K874787 (1987). 27 ancestors in all. 3 later devices descend from it, 1 citing it directly. 4 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 7 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 6 generations backK013660 GenetraRadiomed Corporation · 2001
- 5 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 4 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 3 generations backK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- 2 generations backK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- 1 generation backK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
- This deviceK123137 Calypso SystemVarian Medical Systems · 2012
- Descendant · cites it directly · 2 of its ownK140823 Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK170570 Anchored Beacon (R) transponder, Anchored transponder, Beacon Care…Varian Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK152761 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon…Varian Medical Systems, Inc. · 2015
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014 · cites it directly2descendants
- K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc. · 2018 · 2 generations on0descendants
- K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −7 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −6 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −5 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −4 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −3 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| −2 | K102373 | Calypso System with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2010 | — |
| −1 | K112768 | Calypso Systems with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2011 | — |
| 0 (this device) | K123137 | Calypso System | Varian Medical Systems | 2012 | — |
| +1 | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | Varian Medical Systems, Inc. | 2014 | — |
| +2 | K170570 | Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package -… | Varian Medical Systems, Inc. | 2018 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K060906 | Calypso 4D Localization SystemSummary page 1…ication: CFR 892.5050 Class 11 Product code: LYE Predicate devices: Calypso System (K060906, K102373, KI 12768) Device Description: The Calypso System utilizes non-ionizing electromagnetic and optical technology to prov… | 2006 |
| * | K102373 | Calypso System with Dynamic Edge GatingSummary page 1…CFR 892.5050 Class 11 Product code: LYE Predicate devices: Calypso System (K060906, K102373, KI 12768) Device Description: The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accur… | 2010 |
| * | K112768 | Calypso Systems with Dynamic Edge Gating | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | 2014 | 2 |
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 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 27 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K140823 (Varian Medical Systems, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K060906.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 contous localization of a treatment isocenter by using two or more Beacon transponders. The optional Dynamic Edget m Gating component may signal a radiation therapy system to impose a beam-hold when the…
Read the full statement (201 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 contous localization of a treatment isocenter by using two or more Beacon transponders.
The optional Dynamic Edget m Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-bold upon the targets return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation thierapy treatment systems with external gating interfaces.
Implanted Beacon® transponders axe indicated for use to radiographically and electromagnetically mark soft tissue for fixture therapeutic procedures.
Permanent Beacon transponders ar indicated for implantation in the prostate and the peri-prostatic tissue (i-e., prostatic bed) to align and monitor the treatment isocenter in real time dining radiation therapy
Surface Beacon® transponders are indicated for temporary external placement on the skin to monitor respiratory motion and other patient motion in real time during radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123137: Calypso System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123137
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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