Devices · Brainlab AG

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

Brainlab AG is listed for 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). The FDA list gives July 14, 2023 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QIH as “Automated Radiological Image Processing Software”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223106

Official FDA database record

Date of final decision

July 14, 2023

Company on the FDA list

Brainlab AG

Lead panel

Radiology

Primary product code

QIH

openFDA device name for the code

Automated Radiological Image Processing Software

Device class

2

Regulation number

892.2050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary