BRAINSCAN

System, Planning, Radiation Therapy Treatment

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainscan.

Pre-market Notification Details

• Device ID: K994413
• 510k Number: K994413
• Device Name: BRAINSCAN
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551
• Contact: Stefan Vilsmeier
• Correspondent: Stefan Vilsmeier; BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-29
• Decision Date: 2000-07-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056481000684	K994413	000