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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K850330
Device Name ANGIOTEC SC 1221 SCAN CONVERTER
Applicant
Angiotec
384 Beach Rd.
Burlingame,  CA  94010
Applicant Contact TERRY ROURKE
Correspondent
Angiotec
384 Beach Rd.
Burlingame,  CA  94010
Correspondent Contact TERRY ROURKE
Regulation Number892.2030
Classification Product Code
LMA  
Date Received01/28/1985
Decision Date 04/30/1985
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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