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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K213650
Device Name ThermPix Thermovisual Camera
Applicant
Usa Therm, Inc.
21550 Biscayne Blvd., Suite 133
Aventura,  FL  33180
Applicant Contact Ariel Soffer
Correspondent
Medical Device Academy
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received11/19/2021
Decision Date 04/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
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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