Identifiers
- 510(k) Number
- K013878 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The V-Works is a Medical Imaging Software (Product Code: LLZ) designed for the display, processing, and 3D visualization of DICOM 3.0 compliant medical image files, including those from CT, MRI, and 3D ultrasound scans. It enables radiologists, clinicians, and referring physicians to acquire, render, review, store, print, and distribute image studies for diagnostic evaluation and treatment planning.
This software is supplied as a standalone application for use in radiology and clinical settings, with no specified sterility or single-use requirements. It is classified under FDA’s Radiology advisory committee and holds FDA 510(k) clearance (K013878) as substantially equivalent to a predicate device. No MRI safety classification or physical size specifications are provided in the regulatory data.
Frequently asked questions
What types of medical images can the V-Works software process and visualize for diagnostic use?
The V-Works software is designed to handle DICOM 3.0 compliant image files from CT scans, MRI studies, and 3D ultrasound scans. This means it supports the visualization and processing of these modalities for radiologists, clinicians, and referring physicians to review, analyze, and plan treatments based on the imaging data.
Is the V-Works software intended for single-use or repeated use in clinical settings?
The V-Works software is supplied as a standalone application with no specified sterility or single-use requirements. This indicates it is intended for repeated use in radiology and clinical settings, allowing continuous access for diagnostic evaluation and treatment planning.
How is the V-Works software distributed or supplied to healthcare facilities?
The V-Works software is supplied as a standalone application, meaning it is installed directly on a computer system within radiology or clinical settings. It does not require physical packaging or sterility considerations, as it is a digital solution rather than a physical medical device.
What regulatory pathway was followed for the FDA clearance of the V-Works software?
The V-Works software received FDA clearance through a 510(k) submission, specifically under the Radiology advisory committee (RA). The clearance was granted as substantially equivalent to a predicate device, using a traditional review process, and the decision was made on December 7, 2001.
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: CYBERMED, INC., V-WORKS (K013878) — FDA 510(k) | Innolitics, Cybermed Inc., V-Works | allmed.wiki, Company | Cybermed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013878 | Class II | Active |
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Manufacturer
- Manufacturer
- Cybermed Inc.
- FDA Applicant
- Cybermed, Inc.
Sources (1)
- FDA 510(k) K013878 24 fields · synced Sep 19, 2026