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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 K182815
Device Name XVWeb 3D
Applicant
Apteryx, Inc.
313 S High St. Suite 200
Akron,  OH  44308
Applicant Contact Mark Gniewek
Correspondent
Apteryx, Inc.
313 S High St. Suite 200
Akron,  OH  44308
Correspondent Contact Mark Gniewek
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/03/2018
Decision Date 11/30/2018
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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