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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 K873618
Device Name STEREOTIX
Applicant
Thomson-Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Applicant Contact MARY-JO LYONS
Correspondent
Thomson-Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Correspondent Contact MARY-JO LYONS
Regulation Number892.1710
Classification Product Code
IZH  
Date Received09/08/1987
Decision Date 11/16/1987
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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