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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 K182590
Device Name 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
Applicant
Ge Healthcare
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Veronica Meridith
Correspondent
Ge Healthcare
1515 Danner Dr.
Aurora,  OH  44202
Correspondent Contact Veronica Meridith
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/20/2018
Decision Date 10/19/2018
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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