Identifiers
- 510(k) Number
- K201365 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 True 3D Viewer is a device used for viewing three-dimensional medical images. It is designed to display volumetric data from medical imaging modalities such as CT, MRI, and ultrasound in a true three-dimensional format.
The device is supplied as a software-based system intended for use in clinical radiology settings. It is provided as a reusable software platform requiring compatible hardware and is not sterile or single-use. The device received FDA 510(k) clearance (K201365) on July 17, 2020, and is authorized for marketing in the United States under product code LLZ.
Frequently asked questions
What is the True 3D Viewer used for?
The True 3D Viewer is used to display three-dimensional medical images from CT, MRI, and ultrasound modalities in a true 3D format, enabling clinicians to visualize volumetric data for diagnostic and planning purposes in clinical radiology settings.
How is the True 3D Viewer supplied and is it reusable or single-use?
The True 3D Viewer is supplied as a software-based system that requires compatible hardware to operate. It is designed as a reusable platform, meaning it can be used multiple times after installation and is not intended for single-use or sterile applications.
What regulatory authorization does the True 3D Viewer have and when was it cleared?
The True 3D Viewer received FDA 510(k) clearance under submission number K201365 on July 17, 2020, and is authorized for marketing in the United States under product code LLZ, indicating it was found substantially equivalent to a legally marketed predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201365 | Class II | Active |
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Manufacturer
- Manufacturer
- Echopixel, Inc.
Sources (1)
- FDA 510(k) K201365 24 fields · synced Sep 23, 2026