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FDA 510(k)

RayStation 10.1

K-Number: K210645 · 2021-06-29

ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2021-06-29
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RayStation 10.1 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 2021-06-29 under 510(k) number K210645. 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 10.1?

RayStation 10.1 is a medical device that received FDA 510(k) clearance on 2021-06-29. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K210645.

When did RayStation 10.1 receive FDA 510(k) clearance?

RayStation 10.1 received FDA 510(k) clearance on 2021-06-29, under 510(k) number K210645.

Who is the listed applicant for RayStation 10.1?

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 10.1?

The FDA product code for RayStation 10.1 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.

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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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