RADIOMED MARKER


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K022326
Device Name RADIOMED MARKER
Original Applicant
RADIOMED CORPORATION
one industrial way
tyngsboro, 
MA 
01879 -1400

Original Contact gordon roberts
Regulation Number 892.1750
Classification Product Code
JAK  
Subsequent Product Code
IYE  
Date Received 07/18/2002
Decision Date 01/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No