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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Rectilinear, Nuclear
510(k) Number K780395
Device Name IMAGER, BODY SECTION, RADIONUCLIDE
Applicant
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1300
Classification Product Code
IYW  
Date Received03/13/1978
Decision Date 03/31/1978
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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