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

Clearance record K182234

Optima XR240amx · Ge Medical Systems, LLC · decided 2018-09-06 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
OptimaXR240amx HD Upgrade Gen2GE Medical Systems, L.L.C.IZL MQB00840682145749