SURGIVISION INC. CLEARPOINT SYSTEM


Device Classification Name

neurological stereotaxic instrument, real-time intraoperative mri

510(k) Number K111073
Device Name SURGIVISION INC. CLEARPOINT SYSTEM
Applicant
SURGI-VISION, INC.
5 musick
irvine, 
CA 
92618

Applicant Contact edward waddell
Correspondent
SURGI-VISION, INC.
5 musick
irvine, 
CA 
92618

Correspodent Contact edward waddell
Regulation Number 882.4560
Classification Product Code
ORR  
Subsequent Product Code
LNH  
Date Received 04/18/2011
Decision Date 06/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No