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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, Mammographic
510(k) Number K973856
Device Name GIOTTO HT
Applicant
Sitco, Inc.
25663 Hillview Ct.
Mundelein,  IL  60060
Applicant Contact ROBERT H MCCARTHY
Correspondent
Sitco, Inc.
25663 Hillview Ct.
Mundelein,  IL  60060
Correspondent Contact ROBERT H MCCARTHY
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/09/1997
Decision Date 11/21/1997
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
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