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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 K950431
Device Name LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
Applicant
Open Mri, Inc.
3521 Investment Blvd., Suite 5
Hayward,  CA  94545
Applicant Contact DEBRA REINKING
Correspondent
Open Mri, Inc.
3521 Investment Blvd., Suite 5
Hayward,  CA  94545
Correspondent Contact DEBRA REINKING
Regulation Number892.2020
Classification Product Code
LMD  
Date Received02/02/1995
Decision Date 05/04/1995
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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