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Digisonics Inc

United StatesFDA applicant, unverified

Digisonics Inc is a medical device manufacturer, with 7 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 6 FDA recalls as of 13 Nov 2026.

Devices
7
FDA recalls
61 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 4
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 7
FDA recalls
Identifiers
  • DUNS 099807927

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Digisonics Inc makes

Digisonics Inc manufactures radiological Picture Archiving and Communication System (PACS) software, including tools for fetal growth analysis, obstetric imaging review, and ultrasound data management. Their portfolio includes systems for storing, retrieving, and analyzing medical images, such as the OB-500 Fetal Growth Analysis with OBLink integration, as well as platforms for collaborative radiology reviews like the Doctors Review System and ECHO-COMP.

The company’s devices are classified under FDA Class II and are authorised through the 510(k) premarket notification process and the FDA’s Unique Device Identification (UDI) system. These products are listed in the FDA’s regulatory databases and are intended for use within the United States.

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

Catalogue7

Newest first, rows 1-7 of 7

  • DigiView 4.0

    Listed Registry: GUDID Class:II

  • OBView 4.8

    Listed Registry: GUDID Class:II

  • DigiView 3.8

    Listed Registry: GUDID Class:II

  • OBView 4.9

    Listed Registry: GUDID Class:II

  • Model Ob-500 Fetal Growth Analysis & Option Oblink Ref K900271

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

  • Echo-Comp Ref K800766

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

  • Doctors Review System Ref K970402 Open recall

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

Company details

DUNS number
099807927

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Digisonics Inc, the earliest on 2007-02-09 and the most recent on 2023-06-26. By recorded status: 1 ongoing and 5 terminated. The reasons filed fall into these groups: software or firmware and performance or accuracy. 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.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 1
  • 2024 0
  • 2025 0
  • 2026 0

5 initiated before 2017

  • 2023

    • 26 Jun 2023 Z-2214-2023 Class II Ongoing Software issue Distribution: US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY, UT, PA, MA, GA, VA, WA, WI, and Internationally…
      Full distribution text US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY, UT, PA, MA, GA, VA, WA, WI, and Internationally to :Aruba
      Submission number: K970402

  • 2009

    • 6 Feb 2009 Z-2193-2011 Unclassified (pre-2012) Terminated Left ventricle volume was inaccurate when the volumes were measured from images having different scales. Distribution: Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand. Submission number: K970402
    • 20 Jan 2009 Z-2180-2011 Unclassified (pre-2012) Terminated Data from one patient's study had the potential for being put into another patient's report. Distribution: Worldwide Distribution -- USA including States of : OH, NC, LA, TX, CA, MO, NY, MD, MA, DC, IA, AZ, PA, MI, NC, FL, IN,…
      Full distribution text Worldwide Distribution -- USA including States of : OH, NC, LA, TX, CA, MO, NY, MD, MA, DC, IA, AZ, PA, MI, NC, FL, IN, SC, ID, MN, AR, OK, IL, CT, and countries of Canada, Lebanon, and New Zealand.
      Submission number: K970402

  • 2008

    • 4 Nov 2008 Z-2166-2011 Unclassified (pre-2012) Terminated Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed. Distribution: Worldwide Distribution -- USA including States of : TX, OH, NC, MA, NY, IL, FL, OK, MO, ID, AZ, AR, MI CA, MD, and…
      Full distribution text Worldwide Distribution -- USA including States of : TX, OH, NC, MA, NY, IL, FL, OK, MO, ID, AZ, AR, MI CA, MD, and country of Canada. *** Due to the age of this recall, district is recommending no audit checks***
      Submission number: K970402
    • 12 May 2008 Z-2066-2011 Unclassified (pre-2012) Terminated Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report Distribution: Nationwide Distribution including OK

  • 2007

    • 9 Feb 2007 Z-2113-2011 Unclassified (pre-2012) Terminated Study would on occasion have fetal heart rate and/or cervical length on the report that was not entered nor did it belong to that patient. Software displayed incorrect data for fetal heart rate and cervical length in OB ultrasound reports. Distribution: Worldwide distribution: USA (nationwide) and country of Canada. Submission number: K970402

Frequently asked questions

How many devices does Digisonics Inc have in the registry?

The registry currently lists 7 devices for Digisonics Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list Digisonics Inc's devices?

Among its 7 most recently registered devices, Digisonics Inc has devices listed in FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Digisonics Inc's devices fall under?

Among its 7 most recently registered devices, the classes recorded for Digisonics Inc's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Digisonics Inc?

FDA recall records list 6 recalls initiated by Digisonics Inc, the most recent initiated on 26 Jun 2023. 1 of them is recorded as ongoing. 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 Digisonics Inc in the registry?

The most recently registered devices listed for Digisonics Inc include DigiView 4.0, OBView 4.8, DigiView 3.8 and OBView 4.9.

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