Monaco RTP System— 510(k) K213787

Substantially Equivalent

Elekta Solutions AB

FDA 510(k) clearance K213787 for Monaco RTP System, Substantially Equivalent on 2022-05-17. Applicant: Elekta Solutions AB.

Clearance details

Applicant: Elekta Solutions AB
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2021-12-06
Decision date: 2022-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

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