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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K931186
Device Name PHOTOPHONE MULTIVIEW
Applicant
Image Data Corp.
11550 Ih 10 W.
Suite 200
San Antonio,  TX  78230
Applicant Contact LARRY BUERK
Correspondent
Image Data Corp.
11550 Ih 10 W.
Suite 200
San Antonio,  TX  78230
Correspondent Contact LARRY BUERK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/09/1993
Decision Date 11/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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