WorkstationOne Breast Imaging Workstation
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- WorkstationOne EUDAMEDWorkstationOne™ FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- WorkstationOne EUDAMEDWorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. FDA UDI
- Model / Reference
- 1.9.3 EUDAMEDFDA UDIWS1 EUDAMED
- Description
- WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B148WSONE1930 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B148WSONE1939Y EUDAMED
- Direct Marketing DI
- B148WSONE1930 EUDAMED
- 510(k) Number
- FDA Product Code
- LLZ FDA 510(k)FDA UDI
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The WorkstationOne Breast Imaging Workstation is a digital imaging software platform designed for radiologists to review and interpret breast imaging studies. It integrates digital mammography workflows, enabling efficient analysis and interpretation of breast imaging data in a structured enterprise environment.
This workstation is supplied as software for installation on compatible hardware and is intended for use in radiology departments or imaging centers. It is not classified as a single-use or reusable device, nor does it require sterility or specific MRI safety considerations. Authorized for use under FDA 510(k) clearance and MDR compliance, it supports standardized breast imaging review workflows.
Frequently asked questions
What types of breast imaging studies can the WorkstationOne Breast Imaging Workstation analyze and interpret?
The WorkstationOne Breast Imaging Workstation is specifically designed for reviewing and interpreting digital mammography studies. It integrates workflows to help radiologists efficiently analyze breast imaging data, such as digital mammograms, in a structured enterprise environment. It does not support other imaging modalities like MRI, ultrasound, or CT scans.
Is the WorkstationOne Breast Imaging Workstation a standalone device, or does it require installation on existing hardware?
The WorkstationOne Breast Imaging Workstation is software-only and must be installed on compatible hardware provided by the user. It is not a physical device but rather a digital platform that enhances radiology workflows for digital mammography interpretation.
How is the WorkstationOne Breast Imaging Workstation regulated, and what does that mean for its use in clinical settings?
The WorkstationOne Breast Imaging Workstation holds FDA 510(k) clearance and MDR compliance, meaning it has undergone regulatory review to demonstrate substantial equivalence to a predicate device. This allows its use in radiology departments or imaging centers for digital mammography workflows, but it does not require sterility or single-use considerations since it is a software-based solution.
Does the WorkstationOne Breast Imaging Workstation support multi-user access or is it designed for individual radiologists?
While the WorkstationOne is a software platform, its intended use is within an enterprise environment, suggesting it is designed to support multi-user access in radiology departments or imaging centers. However, specific licensing or user limits would depend on the hardware configuration and software licensing terms set by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: WorkstationOne - Three Palm Software, Three Palm Software - software for medical imaging, WorkstationOne for Breast Imaging - Lamb Technologies
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K073272 | Class II | Active |
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Manufacturer
- Manufacturer
- Three Palm Software, LLC
Sources (3)
- FDA 510(k) K073272 24 fields · synced Sep 18, 2026
- FDA UDI 60587279-009f-4eff-bd28-923f2fb2840c 35 fields · synced May 30, 2026
- EUDAMED 168cf023-5d9d-4755-ae87-d19ff627e130 61 fields · synced Jul 10, 2026