ORR

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Product code: ORR
Device name: Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Device class: Class 2
21 CFR: 21 CFR 882.4560
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 4

FDA classification definition

To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ORR

Classification and pathway per current FDA publications. Data from openFDA (CC0).