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Cuattro UnoMD

by Cuattro, LLC 510(k)

Active United States

510(k) K093480

Overview

The Cuattro UnoMD is a Radiographic Image Processing Workstation (Product Code LLZ) designed to enhance and manage digital radiographic images. It functions as a software solution integrated with existing digital image capture systems, ensuring compatibility with DICOM 3.0 standards for seamless connectivity and data transfer in radiology workflows.

This device operates on a workstation computer equipped with Ethernet capabilities, enabling radiologists to process, store, and distribute radiographic images. Supplied as a software-based solution, it is intended for single-use in clinical settings where image processing and archiving are required. The Cuattro UnoMD holds FDA 510(k) clearance (K093480) under the Radiology Advisory Committee, with no explicit sterility or MRI safety requirements stated in the regulatory filing.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093480 Date5 Mar 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Cuattro, LLC

  • CuattroDR

    Class II

Questions

  • What is the Cuattro UnoMD designed for?

    The Cuattro UnoMD is a Radiographic Image Processing Workstation designed to enhance, process, and manage digital radiographic images in clinical settings. It integrates with existing digital image capture systems using DICOM 3.0 standards, enabling radiologists to efficiently store, review, and distribute images for diagnostic purposes.

  • How is the Cuattro UnoMD supplied and used?

    The Cuattro UnoMD is supplied as a software-based solution for installation on a workstation computer with Ethernet connectivity. It is intended for single-use in clinical environments where radiologists need to process and archive radiographic images, ensuring compatibility with existing digital imaging infrastructure.

  • Does the Cuattro UnoMD require sterility or MRI safety considerations?

    The Cuattro UnoMD does not have explicit sterility or MRI safety requirements as stated in its regulatory filing. Since it is a software-based solution installed on a workstation, these considerations do not apply to the device itself.

  • What regulatory clearance does the Cuattro UnoMD hold?

    The Cuattro UnoMD holds FDA 510(k) clearance (K093480) under the Radiology Advisory Committee, classified as substantially equivalent to a predicate device. The clearance was granted in 2010 following a traditional review process.

  • Is the Cuattro UnoMD compatible with other imaging systems?

    Yes, the Cuattro UnoMD is designed to integrate seamlessly with existing digital image capture systems through DICOM 3.0 compatibility. This ensures compatibility for data transfer and workflow integration in radiology departments.