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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K223009
Device Name Wireless/Wired X-Ray Flat Panel Detectors
Applicant
Allengers Medical Systems Limited
Fda Hall Unit-2, Bhankarpur, Mubarakpur Rd.
Derabassi, Distt. Mohali,  IN 140507
Applicant Contact Sanjeev K. Marjara
Correspondent
Allengers Medical Systems Limited
Fda Hall Unit-2, Bhankarpur, Mubarakpur Rd.
Derabassi, Distt. Mohali,  IN 140507
Correspondent Contact Sanjeev K. Marjara
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/29/2022
Decision Date 11/27/2022
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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