4D Viewer Radiology USWP-100A

No FDA recalls found in the data synced 22 Oct 2026.

Full name

4D Viewer Radiology, Model Uswp-100A

510(k) Number

K082684 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Ssa-390A/Power Vision 8000

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See all devices from Toshiba America Medical Systems, In.C →

• What is the 4D Viewer Radiology USWP-100A used for?

  The 4D Viewer Radiology USWP-100A is a picture archiving and communications system (PACS) software designed specifically for radiology workstations. It processes and displays four-dimensional ultrasound volume datasets in DICOM format, enabling volumetric and temporal visualization. This software integrates with Toshiba ultrasound systems to provide diagnostic tools for physicians, including measurement packages for volumetric and temporal assessments. It is intended to enhance diagnostic workflows in clinical radiology settings by improving the analysis of ultrasound data.

• How is the 4D Viewer Radiology USWP-100A supplied?

  The 4D Viewer Radiology USWP-100A is supplied as a standalone software package. It does not require physical installation like hardware devices but must be installed on compatible radiology workstations. The software is designed to interface with Toshiba ultrasound systems for data acquisition, ensuring seamless integration into existing diagnostic workflows.

• Is the 4D Viewer Radiology USWP-100A single-use or reusable?

  The 4D Viewer Radiology USWP-100A is a reusable software solution. Since it operates as a digital tool installed on workstations, it is not subject to single-use or sterility requirements. It can be used repeatedly across multiple diagnostic sessions, provided the workstation and system compatibility are maintained.

• What compatibility requirements does the 4D Viewer Radiology USWP-100A have?

  The 4D Viewer Radiology USWP-100A is designed to work exclusively with Toshiba ultrasound systems. It requires integration with these systems to acquire and process ultrasound data for 4D visualization. Ensure your radiology workstation meets the technical specifications for running the software, as compatibility is critical for proper functionality.

• What regulatory clearance does the 4D Viewer Radiology USWP-100A hold?

  The 4D Viewer Radiology USWP-100A holds FDA 510(k) clearance under the Radiology Advisory Committee. It was classified as substantially equivalent to a predicate device and received clearance with the designation K082684. This clearance confirms its compliance with U.S. regulatory standards for radiology PACS software.