GORE 3.0T TORSO ARRAY


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K023679
Device Name GORE 3.0T TORSO ARRAY
Original Applicant
W.L. GORE & ASSOCIATES,INC
750 ott’s chapel rd.
newark, 
DE 
19713

Original Contact tracy wolf
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/01/2002
Decision Date 11/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No