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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K254143
Device Name EM-TECH Passive Ultrasound Probe Strap
Applicant
EM-TECH Solutions, Inc.
25272 Mcintyre Sq.
Chantilly,  VA  20152
Applicant Contact Enayatullah Motahedy
Correspondent
EM-TECH Solutions, Inc.
25272 Mcintyre Sq.
Chantilly,  VA  20152
Correspondent Contact Enayatullah Motahedy
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/22/2025
Decision Date 08/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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