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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Orthovoltage, Therapeutic X-Ray
510(k) Number K900932
Device Name 37-702 AND 37-703 PC RAINBOW
Applicant
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact GLASSER
Correspondent
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact GLASSER
Regulation Number892.5900
Classification Product Code
IYI  
Date Received02/28/1990
Decision Date 12/05/1990
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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