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Netra Workstation and NetraMD Software

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003484

by Scimage, Inc.

Identifiers

510(k) Number
K003484 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 Netra Workstation and NetraMD Software is a radiological image processing system. It is designed to function as an imaging workstation system in conjunction with software to facilitate the processing of medical images.

This device is identified by FDA 510(k) clearance K003484. It is classified under the radiology medical specialty and is categorized as a class 2 device.

Frequently asked questions

What is the primary function of the Netra Workstation and NetraMD Software?

This device is a radiological image processing system. It is specifically designed to function as an imaging workstation in conjunction with software to assist clinicians in the processing of medical images.

What is the regulatory status of this imaging system?

The Netra Workstation and NetraMD Software has received FDA 510(k) clearance, identified by the number K003484. It is classified as a class 2 device within the radiology medical specialty.

How is this device categorized for regulatory purposes?

The system is categorized under the radiology medical specialty and is assigned the product code LLZ. It underwent a traditional 510(k) review process and was determined to be substantially equivalent to existing devices.

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: NETRA WORKSTATION AND NETRAMD SOFTWARE (K003484) - Innolitics, NETRA WORKSTATION AND NETRAMD SOFTWARE 510(k) K003484 - fda.report, NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE (K960911) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Scimage, Inc.

Sources (1)

  • FDA 510(k) K003484 24 fields · synced Sep 22, 2026