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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K052341
Device Name AJEX 9015/135H PORTABLE X-RAY
Applicant
Jpi America, Inc.
141 Central Ave., Suite A
Farmingdale,  NY  11735
Applicant Contact ABE ELGOHARY
Correspondent
Jpi America, Inc.
141 Central Ave., Suite A
Farmingdale,  NY  11735
Correspondent Contact ABE ELGOHARY
Regulation Number892.1720
Classification Product Code
IZL  
Date Received08/26/2005
Decision Date 10/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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