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FDA 510(k)

Monaco RTP System

K-Number: K190178 · 2019-03-29

ApplicantElekta, Inc.
Decision Date2019-03-29
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Monaco RTP System is the device name listed in this FDA 510(k) record. The listed applicant is Elekta, Inc.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K190178. 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?

Monaco RTP System is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Elekta, Inc.. The 510(k) number is K190178.

When did Monaco RTP System receive FDA 510(k) clearance?

Monaco RTP System received FDA 510(k) clearance on 2019-03-29, under 510(k) number K190178.

Who is the listed applicant for Monaco RTP System?

The FDA 510(k) record lists Elekta, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monaco RTP System?

The FDA product code for Monaco RTP System is MUJ.

Other records listing Elekta, Inc. 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.

K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDK192482Elekta UnityK192242Synergy Platform, Synergy, Infinity, VersaHDK183037Monaco RTP SystemK183034MOSAIQ Oncology Information SystemK182076Elekta Unity

View all 7 devices →

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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