Cleared Traditional

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

K232759 · Brainlab AG · Radiology
May 2024
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K232759 is an FDA 510(k) clearance for the Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Brainlab AG (M?nich, DE). The FDA issued a Cleared decision on May 21, 2024, 256 days after receiving the submission on September 8, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K232759 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2023
Decision Date May 21, 2024
Days to Decision 256 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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