Cleared Traditional

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

K243633 · Brainlab AG · Radiology

Jun 2025

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K243633 is an FDA 510(k) clearance for the Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (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 June 13, 2025, 200 days after receiving the submission on November 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K243633 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2024
Decision Date	June 13, 2025
Days to Decision	200 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.