A-SCAN 100


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K024114
Device Name A-SCAN 100
Original Applicant
OPHTHALMIC TECHNOLOGIES, INC.
377 rt 17 s
hasbrouck heights, 
NJ 
07604

Original Contact george h myers
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 12/13/2002
Decision Date 01/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No