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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 K233698
Device Name True Enhance DL
Applicant
GE Healthcare Japan Corporation
7-127, Asahigaoka, 4-chome
Hino-shi,  JP 191-8503
Applicant Contact Laura Turner
Correspondent
GE Healthcare Japan Corporation
7-127, Asahigaoka, 4-chome
Hino-shi,  JP 191-8503
Correspondent Contact Laura Turner
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/17/2023
Decision Date 04/11/2024
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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