DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K033244
Device Name DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
Applicant
GE MEDICAL SYSTEMS, INC.
3000 n. grandview blvd.
mail stop w-400
waukesha, 
WI 
53188

Applicant Contact larry a kroger
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received 10/07/2003
Decision Date 10/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls