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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, Stationary
510(k) Number K192541
Device Name DigiX FDX
Applicant
Allengers Medical Systems Limited
Bhankharpur, Mubarakpur Rd.
Derabassi, Distt Mohali,  IN 140507
Applicant Contact Sanjeev K. Marjara
Correspondent
Allengers Medical Systems Limited
Bhankharpur, Mubarakpur Rd.
Derabassi, Distt Mohali,  IN 140507
Correspondent Contact Sanjeev K. Marjara
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/16/2019
Decision Date 10/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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