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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomographic
510(k) Number K931815
Device Name 2000 X-RAY - TOMOGRAPHIC
Applicant
Imaging Sciences Intl., Inc.
1308 Meetinghouse Rd.
P.O. Box 73
Gwynedd,  PA  19436
Applicant Contact EDWARD J MARANDOLA
Correspondent
Imaging Sciences Intl., Inc.
1308 Meetinghouse Rd.
P.O. Box 73
Gwynedd,  PA  19436
Correspondent Contact EDWARD J MARANDOLA
Regulation Number892.1740
Classification Product Code
IZF  
Date Received04/08/1993
Decision Date 08/23/1993
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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