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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, Tomography, Computed
510(k) Number K051980
FOIA Releasable 510(k) K051980
Device Name DVT SCANNER
Applicant
Imaging Sciences Intl., Inc.
1910 N. Penn Rd.
Hatfield,  PA  19440
Applicant Contact DAVID W COWAN
Correspondent
Imaging Sciences Intl., Inc.
1910 N. Penn Rd.
Hatfield,  PA  19440
Correspondent Contact DAVID W COWAN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/21/2005
Decision Date 08/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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