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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 K930997
Device Name DOMINATOR RADIOLOGY SYSTEM
Applicant
Dominator Radiology Systems, Inc.
P.O. Box 3784
Rancho Santa Fe,  CA  92067
Applicant Contact MURRY A REICHER
Correspondent
Dominator Radiology Systems, Inc.
P.O. Box 3784
Rancho Santa Fe,  CA  92067
Correspondent Contact MURRY A REICHER
Regulation Number892.2020
Classification Product Code
LMD  
Date Received02/01/1993
Decision Date 04/07/1993
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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