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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K973028
Device Name HELIOS LASER IMAGER 1417
Applicant
Sterling Diagnostic Imaging, Inc.
10 S. Academy St.
Greenville,  SC  29601
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Sterling Diagnostic Imaging, Inc.
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/14/1997
Decision Date 10/28/1997
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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