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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 K122697
Device Name PORTA 100HF
Applicant
Job Corporation
1411 W. 190th St.
Suite 120
Gardena,  CA  92048
Applicant Contact TAKAHIRO HARUYAMA
Correspondent
Job Corporation
1411 W. 190th St.
Suite 120
Gardena,  CA  92048
Correspondent Contact TAKAHIRO HARUYAMA
Regulation Number892.1720
Classification Product Code
IZL  
Date Received09/04/2012
Decision Date 10/05/2012
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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