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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Non-Tilting, Powered
510(k) Number K930273
Device Name ALPHA
Applicant
Raymax Medical Corp.
64 Trowers Rd.
Woodbridge
Ontario, L4l 7k5,  CA
Applicant Contact ARVIND SINGH
Correspondent
Raymax Medical Corp.
64 Trowers Rd.
Woodbridge
Ontario, L4l 7k5,  CA
Correspondent Contact ARVIND SINGH
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received01/19/1993
Decision Date 07/13/1993
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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