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510(k) K180308

Prelude by Medcom GmbH — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2018
Date Received
February 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K092653 — VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 (September 18, 2009)
  • K080742 — VERISUITE 1.6, VERISUITE-PARTICLE 1.6 (May 9, 2008)
  • K032550 — EXOMIO, MODEL 2.0 SP1 (September 25, 2003)
  • K022219 — EXOMIO, MODEL 1.1 (October 7, 2002)

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