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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K934574
Device Name MODEL MPFT-01, GENESIS
Applicant
International Medical Designs, Inc.
303 Elnora Ave.
Deltona,  FL  32738
Applicant Contact GEORGE GRABOWSKI
Correspondent
International Medical Designs, Inc.
303 Elnora Ave.
Deltona,  FL  32738
Correspondent Contact GEORGE GRABOWSKI
Regulation Number892.1980
Classification Product Code
IXR  
Date Received09/16/1993
Decision Date 03/04/1994
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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