RayPilot System – Electromagnetic Tracking for Radiotherapy

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK203722	Date2 Sep 2021Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K203722

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K203722
FDA product code: IYE

Device class: Class II
Regulation: 21 CFR Part 892.5050
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Calypso 4D Localization System K060906 28 Jul 2006 FDA record

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RayPilot System is a real-time electromagnetic tracking device designed for use with linear accelerators in radiotherapy. It continuously monitors and tracks the position of internal anatomical structures, such as the prostate, during treatment sessions to ensure precise targeting and alignment with the radiation beam. This system is classified as a linear accelerator accessory and is intended for integration with existing radiotherapy equipment to enhance treatment accuracy in radiology settings.

The RayPilot System is supplied as a reusable medical device and is intended for use in clinical radiotherapy environments. It is not sterile at the time of shipment but is designed to be cleaned and reprocessed according to standard medical device protocols. The system operates in the electromagnetic spectrum and is compatible with MRI-safe environments, though specific MRI safety certifications should be verified per facility guidelines. Authorized for use in the United States under an FDA 510(k) clearance (K203722), the device adheres to regulatory standards for Class II medical devices under the FDA’s 892.5050 classification. Storage and handling follow manufacturer guidelines to maintain performance and safety.

Devices cleared under K203722

12 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K203722
		UDI-DI	Size and differences
Raypilot Extension Plate 1 Micropos Medical AB (Publ)	2021 / 1	07350007952219	Single use: no	On the market
Raypilot Hypocath 1 Micropos Medical AB (Publ)	1004 / 1	07350007951045	Single use: yes	On the market
Raypilot Matching Network 1 Micropos Medical AB (Publ)	6004 / 1	07350007956040	Single use: no	On the market
Raypilot Power Box 1 Micropos Medical AB (Publ)	6003 / 1	07350007956033	Single use: no	On the market
Raypilot Quality Control Kit 1 Micropos Medical AB (Publ)	4005 / 1	07350007954053	Single use: no	On the market
Raypilot Receiver 1 Micropos Medical AB (Publ)	2020 / 1	07350007952202	Single use: no	On the market
Raypilot Software 1 Micropos Medical AB (Publ)	3004 / 1	07350007953049	Single use: no	On the market
Raypilot System Cable 1 Micropos Medical AB (Publ)	6002 / 1	07350007956026	Single use: no	On the market
Raypilot Table Displacement Meter 1 Micropos Medical AB (Publ)	4007 / 1	07350007954077	Single use: no	On the market
Raypilot Transmitter Cable 1 Micropos Medical AB (Publ)	6001 / 1	07350007956019	Single use: no	On the market
Raypilot Transmitter Tester 1 Micropos Medical AB (Publ)	4006 / 1	07350007954060	Single use: no	On the market
Raypilot Viewcath 1 Micropos Medical AB (Publ)	1005 / 1	07350007951052	Single use: yes	On the market

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).