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Sign in to claim this brandDigisonics Inc
US
Last updated May 25, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Digisonics Inc manufacture?
Digisonics Inc specializes in radiological Picture Archiving and Communication System (PACS) software. These systems are designed to store, retrieve, and analyze medical images, with a focus on obstetric and fetal imaging. Examples include tools like the OB-500 Fetal Growth Analysis system with OBLink integration, as well as platforms for collaborative radiology reviews such as the Doctors Review System and ECHO-COMP. The company’s devices are tailored for managing ultrasound data and enhancing diagnostic workflows in radiology.
Where is Digisonics Inc based, and what does that mean for its regulatory oversight?
Digisonics Inc is based in the United States, which means its devices are subject to FDA regulatory oversight. Since the company’s products fall under radiological PACS software, they are classified under FDA Class II. This classification requires compliance with specific regulatory pathways, such as the 510(k) premarket notification process and the FDA’s Unique Device Identification (UDI) system, ensuring their devices meet safety and performance standards before use in the U.S. market.
Which regulatory registries or databases list Digisonics Inc’s devices?
Digisonics Inc’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of the company’s authorised radiological PACS software, including systems like the OB-500 and Doctors Review System, by documenting their compliance with FDA requirements.
How are Digisonics Inc’s devices classified by the FDA, and why does this matter?
Digisonics Inc’s devices are classified under FDA Class II, which applies to moderate-risk medical products requiring special controls to ensure their safety and effectiveness. This classification means the company must follow specific regulatory pathways, such as the 510(k) process, to demonstrate that their PACS software—like the OB-500 or ECHO-COMP—meets performance standards and reduces risks associated with radiological imaging workflows. Class II classification strikes a balance between ensuring device safety and allowing innovation in medical technology.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 099807927
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DigiView | 4.0 | FDA UDI | Class II | Active |
| OBView | 4.8 | FDA UDI | Class II | Active |
| DigiView | 3.8 | FDA UDI | Class II | Active |
| OBView | 4.9 | FDA UDI | Class II | Active |
| Model Ob-500 Fetal Growth Analysis & Option Oblink | K900271 | FDA 510(k) | Class II | Active |
| Echo-Comp | K800766 | FDA 510(k) | Class II | Active |
| Doctors Review System | K970402 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Digisonics Inc. has six FDA recall records initiated between February 9, 2007, and June 26, 2023. The records include instances where software inaccuracies led to incorrect measurements, such as left ventricle volume discrepancies, incorrect fetal heart rate or cervical length data in OB ultrasound reports, and failures to update measurements after amendments. Other reasons cited include software issues causing misassigned patient data across reports and incorrect data transfer between systems. The recall statuses listed are open, classified, and terminated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 26, 2023 | Z-2214-2023 | — | open, classified | Software issue |
| Feb 6, 2009 | Z-2193-2011 | — | terminated | Left ventricle volume was inaccurate when the volumes were measured from images having different scales. |
| Jan 20, 2009 | Z-2180-2011 | — | terminated | Data from one patient's study had the potential for being put into another patient's report. |
| Nov 4, 2008 | Z-2166-2011 | — | terminated | Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed. |
| May 12, 2008 | Z-2066-2011 | — | terminated | Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report |
| Feb 9, 2007 | Z-2113-2011 | — | 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. |