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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K223514
Device Name Spectral Bone Marrow
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Katelyn Rowley
Correspondent
GE Medical Systems, LLC.
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Katelyn Rowley
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
QIH  
Date Received11/22/2022
Decision Date 03/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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