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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, Fluoroscopic, Image-Intensified
510(k) Number K974058
Device Name FS IV MINI C-ARM SYSTEM
Applicant
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Applicant Contact Nandini Murthy
Correspondent
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Correspondent Contact Nandini Murthy
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/27/1997
Decision Date 01/12/1998
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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