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FDA 510(k)

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

K-Number: K240398 · 2025-04-04

ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2025-04-04
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 is the device name listed in this FDA 510(k) record. The listed applicant is RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K240398. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3?

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K240398.

When did RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 receive FDA 510(k) clearance?

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 received FDA 510(k) clearance on 2025-04-04, under 510(k) number K240398.

Who is the listed applicant for RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3?

The FDA 510(k) record lists RaySearch Laboratories AB (PUBL) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3?

The FDA product code for RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 is MUJ.

Other records listing RaySearch Laboratories AB (PUBL) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252109RayStation (2024A SP3)K242992RayCare (2024A SP1)K222312RayStation 12AK220141RayStation 11BK211867RayStation 11.0K210645RayStation 10.1

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Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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