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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K896223
Device Name PHOTOPHONE
Applicant
IMAGE DATA CORP.
11550 IH 10 WEST
SUITE 200
SAN ANTONIO,  TX  78230
Applicant Contact RONALD E GRAY
Correspondent
IMAGE DATA CORP.
11550 IH 10 WEST
SUITE 200
SAN ANTONIO,  TX  78230
Correspondent Contact RONALD E GRAY
Regulation Number892.2030
Classification Product Code
LMA  
Date Received10/30/1989
Decision Date 02/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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