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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 K250524
Device Name Mendaera Guidance System
Applicant
Mendaera, Inc.
700 S Claremont St.
Suite 200
San Mateo,  CA  94402
Applicant Contact Josh DeFonzo
Correspondent
Mendaera, Inc.
700 S Claremont St.
Suite 200
San Mateo,  CA  94402
Correspondent Contact Polly Ma
Regulation Number892.1570
Classification Product Code
ITX  
Date Received02/21/2025
Decision Date 07/02/2025
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		 Yes
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