BEUDAMED
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    iThera Medical GmbH

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·1 Device

    MSOT Acuity Echo

    Device
    EU MDR · Eu Md Class 2a ·iThera Medical GmbH·On the market·11 countries

    MSOT Acuity Echo

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·iThera Medical GmbH·1 device

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Recall
    Open, Classified ·Ithera Medical Gmbh Zielstattstr. 13 Munich Germany·Product code REK·January 8, 2025