Cleared Traditional

Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

K223106 · Brainlab AG · Radiology

Jul 2023

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K223106 is an FDA 510(k) clearance for the Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0), a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on July 14, 2023, 287 days after receiving the submission on September 30, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K223106 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2022
Decision Date	July 14, 2023
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QIH — Automated Radiological Image Processing Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.