510(k) · Cleared

Cleared

Calypso 4D Localization System

K060906510(k) TraditionalCleared Jul 28, 2006116-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Calypso Medical Technologies, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jul 28, 2006 as substantially equivalent to K983660 (Brainlab, Inc., 1999) and 6 other predicates after a 116-day review. Its family tree reaches back 4 generations to 1994. 4 of the 25 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.

Decided: Jul 28, 2006
Review: 116 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 7

Its longest line of descent runs back 4 generations to K911783 (1994). 13 ancestors in all. 11 later devices descend from it, 8 citing it directly. 4 of the 25 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
3 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
2 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
1 generation backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
This deviceK060906 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006
Descendant · cites it directly · 9 of its ownK080726 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 · cites it directly · 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

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2008high 3 (2012) · low 0 (2009)2026

Class I recalls in this family

K994270 Instatrak 3000 System with Fluorotrak Module…direct predicate · 2000
K983529 Instatrak 3000direct predicate · 1998
K960330 Instatrakdirect predicate · 1996
K981998 Pediatric Instatrak System2 generations back · 1998

Most influential descendants

Showing 5 of 11 · See all

K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · cites it directly9descendants
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 · cites it directly3descendants
K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K911783	Allegro Viewing Wand	I.S.G. Technologies, Inc.	1994	—
−3	K981998	Pediatric Instatrak System	Visualization Technology, Inc.	1998	Class I
−2	K983529	Instatrak 3000	Visualization Technology, Inc.	1998	Class I
−1	K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000	Visualization Technology, Inc.	2000	Class I
0 (this device)	K060906	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2006	—
+1	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	—
+1	K123137	Calypso System	Varian Medical Systems	2012	—
+1	K140823	Permanent Beacon Transponder/Soft Tissue Beacon Transponder	Varian Medical Systems, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	1
1997	1	0
1999	3	0
2001	1	0
2002	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2011	1	0
2012	3	0
2014	2	0
2015	1	0
2018	1	0
2021	1	0

FIG. 1 — Lineage of K060906, 1994–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K983660	Exactrac (Brainlab Patient Positioning System) Summary page 1 …50 Class II Product code - IYE Predicate devices: BrainLAB ExacTrac Patient Positioning System (K983660, K003285, K040585) GE Medical Systems Instatrak System (K960330, K983529, and K994…	Brainlab, Inc.	1999	—
*	K003285	Exac Trac 2.0 (Novalis Body Module) Summary page 1 …Class II Product code - IYE Predicate devices: BrainLAB ExacTrac Patient Positioning System (K983660, K003285, K040585) GE Medical Systems Instatrak System (K960330, K983529, and K994270)…	Brainlab AG	2001	—
*	K040585	Exactrac 4.0 and Exactrac X-Ray 6D Summary page 1 …Class II Product code - IYE Predicate devices: BrainLAB ExacTrac Patient Positioning System (K983660, K003285, K040585) GE Medical Systems Instatrak System (K960330, K983529, and K994270)…	Brainlab AG	2004	—
*	K960330	Instatrak Summary page 1 …xacTrac Patient Positioning System (K983660, K003285, K040585) GE Medical Systems Instatrak System (K960330, K983529, and K994270) Northwest Medical Physics Equipment (NMPE) Aeculoc implante…	Visualization Technology, Inc.	1996	Class I
*	K983529	Instatrak 3000 Summary page 1 …atient Positioning System (K983660, K003285, K040585) GE Medical Systems Instatrak System (K960330, K983529, and K994270) Northwest Medical Physics Equipment (NMPE) Aeculoc implanted fiducia…	Visualization Technology, Inc.	1998	Class I
*	K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000 Summary page 1 …oning System (K983660, K003285, K040585) GE Medical Systems Instatrak System (K960330, K983529, and K994270) Northwest Medical Physics Equipment (NMPE) Aeculoc implanted fiducials (K012575)…	Visualization Technology, Inc.	2000	Class I
*	K012575	Prefernce Imrt Treatment Planning Module Summary page 1 …(K960330, K983529, and K994270) Northwest Medical Physics Equipment (NMPE) Aeculoc implanted fiducials (K012575) Page 5.1 !(a clo G Indications for use: The Calypso® 4…	Northwest Medical Physics Equipment, Inc.	2002	—

Also cleared against K983660: 2 other devices →

What descends from it? (11)

See all 11

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080726	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2008	9
K102373	Calypso System with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	2010	6
K112768	Calypso Systems with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	2011	4
K123137	Calypso System	Varian Medical Systems	2012	3
K140823	Permanent Beacon Transponder/Soft Tissue Beacon Transponder	Varian Medical Systems, Inc.	2014	2
K121663	Clarity	Elekta, Ltd.	2012	1
K203722	RayPilot System	Micropos Medical AB	2021	0
K112841	Surface Beacon Transponders	Calypso Medical Technologies, Inc.	2012	0

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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
K983529Instatrak 3000Visualization Technology, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K960330InstatrakVisualization Technology, Inc. · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
6 of the 13 ancestors have a recall of any class; 4 have a Class I recall.
Of its descendants, K080726 (Calypso Medical Technologies, Inc., 2008) has gone furthest, with 9 descendants of its own.
2 other devices also cite its predicate K983660.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)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 permanent implantation in the prostate only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060906 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060906: Calypso 4D Localization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060906

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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