Prelude

System, Planning, Radiation Therapy Treatment

MedCom GmbH

The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Prelude.

Pre-market Notification Details

• Device ID: K180308
• 510k Number: K180308
• Device Name: Prelude
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293
• Contact: Johannes Messow
• Correspondent: Johannes Messow; MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-02
• Decision Date: 2018-03-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260308110108	K180308	000
04260308110092	K180308	000