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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K253221
Device Name Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
Applicant
Eieling Technology (Shenzhen) Limited
Rm610 And Rm110, Bldg. E, Qihang Innovation Development Park
# 1008 Songbai Rd.,Yangguang Community,Xili St.,Nanshan Dist
Shenzhen,  CN 518108
Applicant Contact Chen Salon
Correspondent
Imd Medical & Drug Technology Service Institutions
Rm. 308, Bldg. 11, # 23 Jinqu Rd., Wanjiang District
Dongguan,  CN 523000
Correspondent Contact Chen Salon
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received09/29/2025
Decision Date 02/06/2026
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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