SPEEDER 1.5T WRIST ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K072935
Device Name SPEEDER 1.5T WRIST ARRAY COIL
Applicant
QUALITY ELECTRODYNAMICS
777 beta dr.
mayfield village, 
OH 
44143

Applicant Contact christie zydyk
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 10/17/2007
Decision Date 10/31/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No