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RayCare 3.1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200487

by RaySearch Laboratories AB (PUBL)

Identifiers

510(k) Number
K200487 FDA 510(k)
FDA Product Code
MUJ 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 RayCare 3.1 is a Radiation Therapy Treatment Planning System (Class II), designed to assist in the planning and delivery of radiation therapy for oncology patients. It provides computational tools for dose calculation, treatment optimization, and contouring to support precise radiation treatment strategies in radiology settings.

This software-based device is intended for use in clinical environments by authorized personnel, requiring no sterility as it is non-invasive and non-reusable. It operates independently of MRI safety concerns and is supplied as a standalone system with no physical consumables. The device holds FDA 510(k) clearance (K200487) under the Radiology advisory committee, with regulatory compliance under 21 CFR 892.5050. Installation and use adhere to manufacturer-provided guidelines for radiation therapy workflows.

Frequently asked questions

What is the primary purpose of the RayCare 3.1 in a clinical setting?

The RayCare 3.1 is a Radiation Therapy Treatment Planning System designed to assist clinicians in planning and delivering precise radiation therapy for oncology patients. It provides computational tools for dose calculation, treatment optimization, and contouring to enhance the accuracy and effectiveness of radiation treatment strategies in radiology environments.

Is the RayCare 3.1 a reusable or single-use device, and does it require sterility?

The RayCare 3.1 is a software-based system and is not reusable or invasive, meaning it does not require sterility. Since it operates digitally without physical contact with patients, sterility is not applicable, and no consumables or reusable components are involved.

How is the RayCare 3.1 supplied, and are there any physical consumables needed?

The RayCare 3.1 is supplied as a standalone software system with no physical consumables required. It operates independently and does not rely on external hardware or disposable items, making installation and use straightforward for authorized personnel in clinical settings.

What regulatory pathway was followed for FDA clearance of the RayCare 3.1?

The RayCare 3.1 received FDA 510(k) clearance (K200487) under the Radiology advisory committee (RA) through a traditional 510(k) review process. It is classified as Class II and complies with 21 CFR 892.5050, ensuring it meets established safety and effectiveness standards for radiation therapy planning systems.

Does the RayCare 3.1 have any compatibility concerns with MRI environments?

No, the RayCare 3.1 is not affected by MRI safety concerns since it is a software-based system and does not involve physical hardware that could interact with magnetic fields. This makes it suitable for use in radiology departments where MRI compatibility may be a consideration for other devices.

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: Ab (publ) RayCare 3.1 - allmed.wiki, Software in radiation therapy and oncology | RaySearch Laboratories, PDF RaySearch Laboratories AB (publ) June 10, 2020 Ms. Viktoria Hammarstedt ..., RaySearch Laboratories AB Announces Advanced Radiation Therapeutics ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
RaySearch Laboratories AB (PUBL)

Sources (1)

  • FDA 510(k) K200487 24 fields · synced Sep 19, 2026