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Biosound Esaote, Inc.

United StatesFDA applicant, unverified

Devices
20
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Biosound Esaote, Inc. makes

Biosound Esaote, Inc. manufactures ultrasound imaging systems, including portable and high-resolution models such as the GALILEO HALLEY, AU5, and 7200 series. The company also produces MRI systems under the E-SCAN brand, including the E-SCAN XQ and E-SCAN variants, alongside specialized ultrasound modifications like the ARTOSCAN M. Additional offerings include the ARCHIMED 4210 and 4220 ultrasound systems and the TECHNOS MP.

These devices are classified as Class II under FDA regulations and are recorded in the 510(k) premarket notification database. The company operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

Newest first, rows 1-20 of 20

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  • Galileo Halley Ref K970703

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

  • AU5 Ultrasound Imaging System Ref K980468

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

  • Modification To Artoscan M Ref K010057

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

  • Archimed 4210 And 4220 Ref K973922

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

  • 7250 Ultrasound Imaging System Ref K982444

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

  • AU6 Ref K990360

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

  • 7200 Ultrasound Imaging System Ref K981293

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

  • E-Scan Mri System Ref K012728

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

  • E-Scan Ref K990968

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

  • 7250 (Megas) Ref K994369

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

  • E-Scan Xq Ref K020164

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

  • Technos Mp, Model AU6 Ref K023255

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

  • Formula For Archimed Ref K974079

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

  • AU5 Ultrasound Imaging System Ref K000931

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

  • Artoscan S Ref K981358

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

  • Modification To E-Scan Ref K001894

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

  • 7230 Ultrasound Imaging System With Tei Ref K010405

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

  • AU5, AU6 Ref K000681

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

  • Sled, Finger, Handle Ref K971942

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

  • AU6 (Technos/Technos Mp) Ultrasound Imaging System (Addition Of 3D Imaging Mode And Musculoskeletal Indication) Ref K014168

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

Rows 1-20 of 20

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 5 recalls initiated by Biosound Esaote, Inc., the earliest on 2003-01-22 and the most recent on 2014-06-26. By recorded status: 5 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2014

    • 26 Jun 2014 Z-2167-2014 Class II Terminated Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit. Distribution: Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN,…
      Full distribution text Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees in Canada
      Submission numbers: K040596, K050326, K110688

  • 2005

    • 6 May 2005 Z-1401-05 Unclassified (pre-2012) Terminated Data may be corrupted upon re-opening archived files. Distribution: Nationwide, Canada and Venezuela. Submission number: K040596
    • 6 May 2005 Z-1402-05 Unclassified (pre-2012) Terminated Data may be corrupted upon re-opening archived files. Distribution: Nationwide, Canada and Venezuela. Submission number: K040596
    • 6 May 2005 Z-1403-05 Unclassified (pre-2012) Terminated Data may be corrupted upon re-opening archived files. Distribution: Nationwide, Canada and Venezuela. Submission number: K040596

  • 2003

    • 22 Jan 2003 Z-0299-03 Unclassified (pre-2012) Terminated Excessive power output due to a faulty voltage controller. Distribution: United States and Canada

Frequently asked questions

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

The registry currently lists 20 devices for Biosound Esaote, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biosound Esaote, Inc.'s devices?

Among its 20 most recently registered devices, Biosound Esaote, Inc. has devices listed in FDA 510(k) (20 devices).

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

Among its 20 most recently registered devices, the classes recorded for Biosound Esaote, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Biosound Esaote, Inc.?

FDA recall records list 5 recalls initiated by Biosound Esaote, Inc., the most recent initiated on 2014-06-26. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

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

The most recently registered devices listed for Biosound Esaote, Inc. include GALILEO HALLEY, AU5 ULTRASOUND IMAGING SYSTEM, MODIFICATION TO ARTOSCAN M and ARCHIMED 4210 AND 4220.

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