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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K864339
Device Name PORTA RAY MODEL 325
Applicant
Porta Ray, Inc.
19 Jefryn Blvd. W.
Deer Park,  NY  11729
Applicant Contact RAY MANEZ
Correspondent
Porta Ray, Inc.
19 Jefryn Blvd. W.
Deer Park,  NY  11729
Correspondent Contact RAY MANEZ
Regulation Number892.1700
Classification Product Code
IZO  
Date Received11/04/1986
Decision Date 12/15/1986
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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