UNISIGHT SYSTEM WITH UNIGATE


Device Classification Name

system, image processing, radiological

510(k) Number K023394
Device Name UNISIGHT SYSTEM WITH UNIGATE
Original Applicant
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
1600 kapidlani blvd.
suite 1224
honolulu, 
HI 
96814

Original Contact david lin
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 10/09/2002
Decision Date 01/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No