510(k) · Cleared
ClearedCalypso System with Dynamic Edge Gating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calypso Medical Technologies, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Sep 30, 2010 as substantially equivalent to K060906 (Calypso Medical Technologies, Inc., 2006) and 1 other predicate after a 41-day review. Its family tree reaches back 6 generations to 1987. 4 of the 32 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Sep 30, 2010
- Review
- 41 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K874787 (1987). 25 ancestors in all. 6 later devices descend from it, 3 citing it directly. 4 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 5 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 4 generations backK013660 GenetraRadiomed Corporation · 2001
- 3 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 2 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 1 generation backK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- This deviceK102373 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 · cites it directly · 3 of its ownK123137 Calypso SystemVarian Medical Systems · 2012
- Descendant · 2 generations on · 2 of its ownK140823 Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK170570 Anchored Beacon (R) transponder, Anchored transponder, Beacon Care…Varian Medical Systems, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK152761 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon…Varian Medical Systems, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011 · cites it directly4descendants
- K123137Calypso SystemVarian Medical Systems · 2012 · cites it directly3descendants
- K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014 · 2 generations on2descendants
- K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc. · 2018 · 3 generations on0descendants
- K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −5 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −4 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −3 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −2 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −1 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| 0 (this device) | 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 | — |
| +1 | K123137 | Calypso System | Varian Medical Systems | 2012 | — |
| +2 | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | Varian Medical Systems, Inc. | 2014 | — |
| +3 | K170570 | Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package -… | Varian Medical Systems, Inc. | 2018 | — |
| +3 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060906 | Calypso 4D Localization SystemSummary page 1…™ Gating Patient localization system Medical charged-particle radiation therapy system CFR 892.5050 Class 11 Product code — LHN, IYE Calypso® 4D Localization System (K060906; K080726) Section 6.0 Page 19 of 1500 Indications for Use: The Calypso 4D Localization System is intended for u… | 2006 |
| * | K080726 | Calypso 4D Localization SystemSummary page 1…Patient localization system Medical charged-particle radiation therapy system CFR 892.5050 Class 11 Product code — LHN, IYE Calypso® 4D Localization System (K060906; K080726) Section 6.0 Page 19 of 1500 Indications for Use: The Calypso 4D Localization System is intended for use as an… | 2008 |
What descends from it? (6)
3 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 23 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 25 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K112768 (Calypso Medical Technologies, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K060906.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102373: Calypso System with Dynamic Edge Gating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102373
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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