Cleared Traditional

ExacTrac Dynamic

K220338 · Brainlab AG · Radiology
Apr 2022
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K220338 is an FDA 510(k) clearance for the ExacTrac Dynamic, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on April 29, 2022, 81 days after receiving the submission on February 7, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K220338 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2022
Decision Date April 29, 2022
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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