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 a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2021-06-29 under approval 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. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K210645.
When was RayStation 10.1 approved by the FDA?
RayStation 10.1 received FDA 510(k) clearance on 2021-06-29, under approval number K210645.
What company makes RayStation 10.1?
RayStation 10.1 is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayStation 10.1?
The FDA product code for RayStation 10.1 is MUJ.
Other Devices by RaySearch Laboratories AB (PUBL)
Related Devices (Code: MUJ)
K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.
K161136Precision Treatment Planning SystemAccuray Incorporated
K160093RayStationRaySearch Laboratories AB (PUBL)
K151435MRCATPhilips Medical Systems MR Finland
K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.
K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose ReviewBrainlab AG
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.