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FDA 510(k)

RayStation 11.0

K-Number: K211867 · 2021-09-08

ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2021-09-08
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RayStation 11.0 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 2021-09-08 under 510(k) number K211867. 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 11.0?

RayStation 11.0 is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K211867.

When did RayStation 11.0 receive FDA 510(k) clearance?

RayStation 11.0 received FDA 510(k) clearance on 2021-09-08, under 510(k) number K211867.

Who is the listed applicant for RayStation 11.0?

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 11.0?

The FDA product code for RayStation 11.0 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.

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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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