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

Clearance record K130884

XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION · Ge Medical Systems F.I. Haifa · decided 2013-04-12 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
DaTQUANT2.0GE Medical Systems Israel, Functional ImagingLLZ00195278011343
DaTQUANT1.0GE Medical Systems Israel, Functional ImagingLLZ00840682119306