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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 K172124
Device Name Televere Podiatry Digital Imaging System
Applicant
Televere Systems
1160 Cavalier Rd.
Arnold,  MD  21012
Applicant Contact Randell Quaal
Correspondent
Technology and Business Law Advisors, LLC
1244 Capuchino
Burlingame,  CA  94010
Correspondent Contact Robert Bakin
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received07/14/2017
Decision Date 11/09/2017
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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