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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 K202521
Device Name PtoleMedic System
Applicant
Lento Medical Innovation, Inc.
15110 Northwest Fwy., Suite 150
Houston,  TX  77040
Applicant Contact David W. Schlerf
Correspondent
Lento Medical Innovation, Inc.
15110 Northwest Fwy., Suite 150
Houston,  TX  77040
Correspondent Contact David W. Schlerf
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/01/2020
Decision Date 05/04/2021
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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