ExacTrac Dynamic

Accelerator, Linear, Medical

Brainlab AG

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

Pre-market Notification Details

• Device ID: K220338
• 510k Number: K220338
• Device Name: ExacTrac Dynamic
• Classification: Accelerator, Linear, Medical
• Applicant: Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829
• Contact: Sadwini Suresh
• Correspondent: Chiara Cunico; Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-02-07
• Decision Date: 2022-04-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056481143978	K220338	000