Cleared Traditional

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface

K240431 · Brainlab AG · Radiology
Jul 2024
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K240431 is an FDA 510(k) clearance for the ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on July 24, 2024, 161 days after receiving the submission on February 14, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K240431 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2024
Decision Date July 24, 2024
Days to Decision 161 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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