SURGI-VISION PROSTATE COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K002916
Device Name SURGI-VISION PROSTATE COIL
Original Applicant
SURGI-VISION, INC.
9250 rumsey rd., suite 100
columbia, 
MD 
21045

Original Contact nancy e taylor
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 09/19/2000
Decision Date 11/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No