FILMSAVER, NT VERSION 5.03


Device Classification Name

system, image processing, radiological

510(k) Number K021072
Device Name FILMSAVER, NT VERSION 5.03
Original Applicant
AMERICAN MEDICAL RESOURCES, LTD. (AMR)
3501 silverside rd. suite 205
wilmington, 
DE 
19810

Original Contact elizabeth n faulstich
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/02/2002
Decision Date 06/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No