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510(k) K100836

CLEARPOINT SYSTEM by Surgivision, Inc. — Product Code ORR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 16, 2010
Date Received: March 24, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Device Class: Class II
Regulation Number: 882.4560
Review Panel: NE
Submission Type

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