Home / Device Classification / ORR

ORR — Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri Class II

FDA Device Classification

Classification Details

Product Code
ORR
Device Class
Class II
Regulation Number
882.4560
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K181195mri interventionsClearPoint SystemNovember 2, 2018
K171257mri interventionsClearPoint SystemOctober 20, 2017
K111073surgi-visionSURGIVISION INC. CLEARPOINT SYSTEMJune 22, 2011
K100836surgivisionCLEARPOINT SYSTEMJune 16, 2010