Cleared Special

ExacTrac Dynamic 1.1.2

K231052 · Brainlab AG · Radiology
May 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K231052 is an FDA 510(k) clearance for the ExacTrac Dynamic 1.1.2, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on May 11, 2023, 28 days after receiving the submission on April 13, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K231052 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2023
Decision Date May 11, 2023
Days to Decision 28 days
Submission Type Special
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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