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RayPilot System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203722

by Micropos Medical AB

Identifiers

510(k) Number
K203722 FDA 510(k)
FDA Product Code
IYE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What is the primary purpose of the RayPilot System in a radiotherapy setting?

The RayPilot System is designed to continuously monitor and track the position of internal anatomical structures, such as the prostate, during radiotherapy sessions. This real-time electromagnetic tracking ensures precise alignment of the radiation beam with the target area, improving treatment accuracy and reducing potential exposure to surrounding healthy tissue.

Is the RayPilot System intended for single-use or reusable applications?

The RayPilot System is explicitly designed as a reusable medical device. It must be cleaned and reprocessed according to standard medical device protocols to maintain safety and performance between clinical uses.

How does the RayPilot System integrate with existing radiotherapy equipment?

The RayPilot System is classified as a linear accelerator accessory and is intended for integration with existing radiotherapy equipment, specifically linear accelerators. Its electromagnetic tracking capabilities enhance the precision of radiation therapy by providing real-time feedback on anatomical positioning during treatment.

What are the storage and handling requirements for the RayPilot System?

The RayPilot System requires adherence to manufacturer guidelines for storage and handling to ensure optimal performance and safety. While it is not sterile at shipment, proper cleaning and reprocessing protocols must be followed before reuse in clinical settings.

Is the RayPilot System compatible with MRI environments, and what considerations should be taken?

The RayPilot System operates in the electromagnetic spectrum and is compatible with MRI-safe environments. However, facilities should verify specific MRI safety certifications for the system to ensure compliance with their facility’s guidelines, as electromagnetic interference risks may vary.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Micropos Medical, The Raypilot System - Micropos Medical, Micropos Medical Announces Initial Clinical Treatments Using Raypilot ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Micropos Medical AB

Sources (1)

  • FDA 510(k) K203722 24 fields · synced Sep 20, 2026