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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K253738
Device Name 3.0T AIR 32CH HNA
Applicant
Ge Healthcare Coils (Usa Instruments, Inc.)
1515 Danner Dr.
Aurora,  OH  44202
Applicant Contact Sahra Nur
Correspondent
Ge Healthcare Coils (Usa Instruments, Inc.)
1515 Danner Dr.
Aurora,  OH  44202
Correspondent Contact Sahra Nur
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/24/2025
Decision Date 01/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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