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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K152195

LOGIQ S8 · GE Healthcare · decided 2015-09-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
LOGIQS8 R3 OLEDGE Ultrasound Korea Ltd.ITX IYN IYO00195278029010
LOGIQS8GE Ultrasound Korea Ltd.ITX IYN IYO00840682117753
LOGIQS8 R1 to R2 UPGGE Ultrasound Korea Ltd.ITX IYN IYO00840682117821
LOGIQS8 R1R2 to R3 UPGGE Ultrasound Korea Ltd.ITX IYN IYO00840682117791