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

Clearance record K183268

AI-Rad Companion (Cardiovascular) · Siemens Medical Solutions USA, Inc. · decided 2019-09-10 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
AI-Rad Companion (Cardiovascular)11270037Siemens Healthcare GmbHJAK04056869251226