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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 K210241
Device Name ImplaStation
Applicant
Prodigident, Inc.
1350 Lake St., Suite 1b
Roselle,  IL  60172
Applicant Contact Andrii Gromov
Correspondent
Prodigident, Inc.
1350 Lake St., Suite 1b
Roselle,  IL  60172
Correspondent Contact Andrii Gromov
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/29/2021
Decision Date 12/03/2021
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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