510(k) · Cleared
ClearedCalypso Systems 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 Nov 18, 2011 as substantially equivalent to K060906 (Calypso Medical Technologies, Inc., 2006) and 2 other predicates after a 57-day review. Its family tree reaches back 7 generations to 1987. 4 of the 31 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 57 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K874787 (1987). 26 ancestors in all. 4 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 · 7 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 6 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 5 generations backK013660 GenetraRadiomed Corporation · 2001
- 4 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 3 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 2 generations backK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- 1 generation backK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- This deviceK112768 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
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −7 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −6 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −5 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −4 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −3 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −2 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| −1 | K102373 | Calypso System with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2010 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2012 | 1 | 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? (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…ation: CFR 892.5050 Class 11 Product code - LHN, LYE Predicate devices: Calypso®R 4D Localization System (K060906, K080726, K] 02373) Device Description: The Calypso System utilizes non-ionizing electromagnetic and opt… | 2006 |
| * | K080726 | Calypso 4D Localization SystemSummary page 1…CFR 892.5050 Class 11 Product code - LHN, LYE Predicate devices: Calypso®R 4D Localization System (K060906, K080726, K] 02373) Device Description: The Calypso System utilizes non-ionizing electromagnetic and optical tech… | 2008 |
| * | K102373 | Calypso System with Dynamic Edge GatingSummary page 3…9 I1198 Technolovical Characteristics - See device comparison table below Feature and/or K102373 Cleared Device Device with Change Specification of Feature/Specification new/modified device… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123137 | Calypso System | 2012 | 3 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 26 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K123137 (Varian Medical Systems, 2012) has gone furthest, with 3 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. 2011, 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® 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 radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon@ transponders. The optional Dynamic EdgeTM Gating component may signal a radiation therapy system to impose a beam-hold when the…
Read the full statement (161 words)
The Calypso® 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 radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon@ transponders.
The optional Dynamic EdgeTM 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-hold upon the target's 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 therapy treatment systems with external gating interfaces.
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/K112768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112768: Calypso Systems with Dynamic Edge Gating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112768
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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