ORR · Class II · 21 CFR 882.4560

FDA Product Code ORR: Neurological Stereotaxic Instrument, Real-time Intraoperative Mri

To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An Mri Suite.

Leading manufacturers include Mri Interventions, Inc. and Surgi-Vision, Inc..

4
Total
4
Cleared
127d
Avg days
2010
Since

FDA 510(k) Cleared Neurological Stereotaxic Instrument, Real-time Intraoperative Mri Devices (Product Code ORR)

4 devices
1–4 of 4
Cleared Nov 02, 2018
ClearPoint System
K181195
Mri Interventions, Inc.
Neurology · 182d
Cleared Oct 20, 2017
ClearPoint System
K171257
Mri Interventions, Inc.
Neurology · 175d
Cleared Jun 22, 2011
SURGIVISION INC. CLEARPOINT SYSTEM
K111073
Surgi-Vision, Inc.
Radiology · 65d

About Product Code ORR - Regulatory Context