Devices · Brainlab AG

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Brainlab AG is listed for Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (K223288). The FDA list gives July 21, 2023 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is HAW. openFDA did not return a classification record for that code in this copy of the data. 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=K223288

Official FDA database record

Date of final decision

July 21, 2023

Company on the FDA list

Brainlab AG

Lead panel

Neurology

Primary product code

HAW

openFDA device name for the code

Neurological Stereotaxic Instrument

Device class

2

Regulation number

882.4560

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary