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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K883317
Device Name DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST
Applicant
S & S X-Ray Products, Inc.
87-93 Jay St.
Brooklyn,  NY  11201
Applicant Contact ALAN P SCHWARTZ
Correspondent
S & S X-Ray Products, Inc.
87-93 Jay St.
Brooklyn,  NY  11201
Correspondent Contact ALAN P SCHWARTZ
Regulation Number892.5710
Classification Product Code
IXI  
Date Received08/05/1988
Decision Date 04/26/1989
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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