3.0T TORSO PHASED ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K030495
Device Name 3.0T TORSO PHASED ARRAY COIL
Applicant
GE MEDICAL SYSTEMS, INC.
p.o. box 414
milwaukee, 
WI 
53201

Applicant Contact larry kroger
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 02/19/2003
Decision Date 03/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No