Monaco RTP System (6.3)
K-Number: K252002 · 2026-02-19
ApplicantElekta Solutions AB
Decision Date2026-02-19
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Monaco RTP System (6.3) is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2026-02-19 under approval number K252002. 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 Monaco RTP System (6.3)?
Monaco RTP System (6.3) is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by Elekta Solutions AB. The 510(k) number is K252002.
When was Monaco RTP System (6.3) approved by the FDA?
Monaco RTP System (6.3) received FDA 510(k) clearance on 2026-02-19, under approval number K252002.
What company makes Monaco RTP System (6.3)?
Monaco RTP System (6.3) is manufactured by Elekta Solutions AB.
What is the FDA product code for Monaco RTP System (6.3)?
The FDA product code for Monaco RTP System (6.3) is MUJ.
Other Devices by Elekta Solutions AB
K203172MOSAIQ Oncology Information System
K212218Advanced Algorithms for Treatment Management Applications (AATMA)
K212114Elekta Unity
K202789Monaco Rtp System
K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
K213787Monaco RTP System
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.