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Sonotech, Inc.

United StatesFDA applicant, unverified

Devices
14

What Sonotech, Inc. makes

Sonotech, Inc. manufactures ultrasound imaging accessories, including ultrasound coupling gels (such as SONOGEL and ULTRABIO), solid and flexible coupling membranes (SCANFLEX, SCANTAC), and lubricants (ENDO-GLIDE, SCANLUBE). Their portfolio also includes ultrasound scanning devices (SONOSCAN, ULTRA IMAGE, ULTRA SCAN) and specialized imaging solutions like the VIVOSONIC system.

The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in ultrasound imaging and coupling applications, adhering to U.S. regulatory standards. The manufacturer is based in the United States.

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

Catalogue14

Newest first, rows 1-14 of 14

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  • Sonogel Ref K953468

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

  • Sonoscan Ref K961692

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

  • Ultramix Ref K962093

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

  • Endo-Glide Ref K013701

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

  • Oasis Ref K964658

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

  • Vivosonic Ref K984562

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

  • Scantec Pad Ref K031894

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

  • Ultrabio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant Ref K042619

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

  • Ultra Image And Ultra Scan Ref K981028

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

  • Scanflex Solid Couplant Membrane Ref K983691

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

  • Scanlube Ref K031222

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

  • Scantac Membrane Or Scantac Strip Ref K013170

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

  • Ultrabio Ref K033178

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

  • Hybrisonic Sheath Ref K983985

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

Rows 1-14 of 14

Frequently asked questions

How many devices does Sonotech, Inc. have in the registry?

The registry currently lists 14 devices for Sonotech, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sonotech, Inc.'s devices?

Among its 14 most recently registered devices, Sonotech, Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Sonotech, Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Sonotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Sonotech, Inc. in the registry?

The most recently registered devices listed for Sonotech, Inc. include SONOGEL, SONOSCAN, ULTRAMIX and ENDO-GLIDE.

Generated automatically from registry data and not verified by a human reviewer.