510(k) · Cleared
ClearedRayPilot System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micropos Medical AB · IYE Accelerator, Linear, Medical
Cleared on Sep 2, 2021 as substantially equivalent to K060906 (Calypso Medical Technologies, Inc., 2006) after a 255-day review. Its family tree reaches back 5 generations to 1994. 4 of the 15 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 2, 2021
- Review
- 255 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911783 (1994). 14 ancestors in all. No later device cites it as a predicate yet. 4 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 4 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 3 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 2 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 1 generation backK060906 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006
- This deviceK203722 RayPilot SystemMicropos Medical AB · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −4 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −3 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −2 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −1 | K060906 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K203722 | RayPilot System | Micropos Medical AB | 2021 | — |
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 |
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? (1)
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 4…21 CFR 892.5050 Class II Product code – IYE Predicate device: Calypso 4D Localization system (K060906) Reference Device: Silicone Foley Catheter 3-way (K063442) Indications for use: The RayPilot® System is intended for u… | 2006 |
| † | K063442 | All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in 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 · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 6 of the 14 ancestors have a recall of any class; 4 have a Class I recall.
- 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. 2021, 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 RayPilot@ 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 RayPilot@ System provides accurate, precise, and continuous localization of a treatment isocenter by using RayPilot@ HypoCath@, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient…
Read the full statement (116 words)
The RayPilot@ 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 RayPilot@ System provides accurate, precise,
and continuous localization of a treatment isocenter by using RayPilot@ HypoCath@, a transmitter located within one
lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification.
The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to
require a urinary catheter for the duration of the radiation treatment, for example due to bladder outlet obstruction or
patients who require a chronic indwelling Foley catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203722 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203722: RayPilot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203722
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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