ORRClass II
Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Neurology · 21 CFR 882.4560
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
MDR events7All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances4All time
Recent MDR events
7 adverse event reports on file
- CLEARPOINT NEUROFeb 2, 2022InjuryClearpoint Neuro, Inc.3002838670-2021-00001
- INSTRUMENT, STEREOTAXICMay 15, 2019MalfunctionMedtronic Navigation, Inc1723170-2019-02362
- INSTRUMENT, STEREOTAXICDec 19, 2018MalfunctionMedtronic Navigation, Inc1723170-2018-06354
- CLEARPONIT SYSTEM SMART GRID SYSTEMNov 14, 2018MalfunctionMri Interventions Inc.3002838670-2018-00004
- CLEARPOINTSep 18, 2017DeathMri Interventions, Inc.1125732-2017-00003
- GENERAL ELECTRIC MR 750WApr 8, 2013OtherGeneral Electric Magnetic ResonanceMW5029731
- CLEARPOINT SYSTEMJan 8, 2013DeathMri Interventions, Inc.1125732-2013-00001
Event type breakdown
Malfunction3
Death2
Injury1
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
4 clearances for this product code