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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 K260114
Device Name Align® Cover and Pad Guidance Tool
Applicant
CIVCO Medical Instruments Co., Inc.
750 Lois Ln.
Coralville,  IA  52241
Applicant Contact James Leong
Correspondent
CIVCO Medical Instruments Co., Inc.
750 Lois Ln.
Coralville,  IA  52241
Correspondent Contact James Leong
Regulation Number892.1570
Classification Product Code
ITX  
Date Received01/14/2026
Decision Date 09/24/2026
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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