510(k) · Cleared
ClearedCalypso 4D Localization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calypso Medical Technologies, Inc. · IYE Accelerator, Linear, Medical
Cleared on May 14, 2008 as substantially equivalent to K060906 (Calypso Medical Technologies, Inc., 2006) and 1 other predicate after a 61-day review. Its family tree reaches back 5 generations to 1987. 4 of the 34 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- May 14, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K874787 (1987). 24 ancestors in all. 9 later devices descend from it, 5 citing it directly. 4 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 4 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 3 generations backK013660 GenetraRadiomed Corporation · 2001
- 2 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 1 generation backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- This deviceK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK123137 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 · cites it directly · 1 of its ownK121663 ClarityElekta, Ltd. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010 · cites it directly6descendants
- K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011 · cites it directly4descendants
- K123137Calypso SystemVarian Medical Systems · 2012 · 2 generations on3descendants
- K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014 · cites it directly2descendants
- K121663ClarityElekta, Ltd. · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −4 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −3 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −2 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −1 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| 0 (this device) | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| +1 | 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 | — |
| +2 | K123137 | Calypso System | Varian Medical Systems | 2012 | — |
| +1 | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | Varian Medical Systems, Inc. | 2014 | — |
| +1 | K121663 | Clarity | Elekta, Ltd. | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 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? (2)
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.
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 24 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K102373 (Calypso Medical Technologies, Inc., 2010) has gone furthest, with 6 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. 2008, 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® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso® System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.
Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.
Permanent Beacon® transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080726 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080726: Calypso 4D Localization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080726
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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