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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K254277
Device Name Embrace Neonatal MRI System
Applicant
Aspect Imaging, Ltd.
27 Shaked St.
Industrial Area Hevel Modi'In
Shoham,  IL 60850
Applicant Contact Yaron Eshel
Correspondent
MCRA
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Alex Cadotte
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received12/30/2025
Decision Date 03/13/2026
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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