INNOVA 4100


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K023178
Device Name INNOVA 4100
Original Applicant
GE MEDICAL SYSTEMS, INC.
3000 n. grandview blvd.
waukesha, 
WI 
53188

Original Contact larry a kroger, ph.d
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received 09/23/2002
Decision Date 11/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls