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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K893978
Device Name MEDISYS RECORD AND VERIFY SYSTEM
Applicant
Medisys, Inc.
35 Walbrooke Rd.
Scarsdale,  NY  10583
Applicant Contact RADHE MOHAN
Correspondent
Medisys, Inc.
35 Walbrooke Rd.
Scarsdale,  NY  10583
Correspondent Contact RADHE MOHAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/02/1989
Decision Date 09/01/1989
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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