510(k) K242496

Device
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
Applicant
Eieling Technology (Shenzhen) Limited
510(k) number
K242496
Product code
IYO
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-19
Date received
2024-08-22
Regulation
892.1560
Classification name
System, Imaging, Pulsed Echo, Ultrasonic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Salon Chen
Address
Rm.610, Bldg. E, Qihang Innovation Development Park # 1008 Songhai Rd., Yangguang Community, Xili St. Nanshan District Shenzhen CN 518052 518052

FDA Registration Numbers

Source Documents

510(k) summary PDF

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