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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 a medical device manufactured by Elekta, Inc.. It received FDA 510(k) clearance on 2019-03-29 under approval 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. It is manufactured by Elekta, Inc.. The 510(k) number is K190178.

When was Monaco RTP System approved by the FDA?

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

What company makes Monaco RTP System?

Monaco RTP System is manufactured by Elekta, Inc..

What is the FDA product code for Monaco RTP System?

The FDA product code for Monaco RTP System is MUJ.

Other Devices by Elekta, Inc.

K183034MOSAIQ Oncology Information System K183037Monaco RTP System

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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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