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Siemens Gammasonics, Inc.

United StatesFDA applicant, unverified

Devices
53

What Siemens Gammasonics, Inc. makes

Siemens Gammasonics, Inc. manufactures nuclear medicine imaging systems, including gamma cameras, emission computed tomography (ECT) carbon fiber pallets, and digital imaging solutions like the Multispect 3 triple detector camera and Diacam gamma camera system. Their portfolio also includes digital subtraction angiography systems (e.g., Digitron 2), digital laser high-performance imagers (Digicam LHP), and specialized protocols such as the Digitron stenosis protocol. Image display workstations and PACS (Picture Archiving and Communication Systems) solutions are also part of their offerings, alongside carbon fiber pallets for imaging equipment.

The company’s devices are regulated under FDA Class I and Class II classifications, with many listed via the 510(k) pathway. Their products are primarily intended for the US market, where they comply with FDA requirements for nuclear imaging, digital radiography, and related diagnostic equipment. No additional regulatory bodies or international listings are specified.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue53

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  • Cardiac Camera Ref K833811

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sienet Archive Server, Isa I, Isa Ii Storage Serve Ref K920310

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hicor Ref K903375

    Active Regimes: 510(k) Registry: 510(k) Class:II

Showing 51-53 of 53