FDA 510(k) Application Details - K002198

Device Classification Name	More FDA Info for this Device
510(K) Number	K002198
Device Name	FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS
Applicant	FLUORO SCAN IMAGING SYSTEMS, INC. 650-B ANTHONY TRAIL NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	WILLIAM J ENGEL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2000
Decision Date	10/17/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review