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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K881993
Device Name PXI (PERSONAL X-RAY IMAGER) 512
Applicant
Oklahoma Digital Technologies, Inc.
2220 NW 113th Pl.
Oklahoma City,  OK  73120
Applicant Contact JOHN BLACKWELL
Correspondent
Oklahoma Digital Technologies, Inc.
2220 NW 113th Pl.
Oklahoma City,  OK  73120
Correspondent Contact JOHN BLACKWELL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/12/1988
Decision Date 09/19/1988
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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