FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K002198
Device Name FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS
Original Applicant
FLUORO SCAN IMAGING SYSTEMS, INC.
650-b anthony trail
northbrook, 
IL 
60062

Original Contact william j engel
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received 07/20/2000
Decision Date 10/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No