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3DNET Suite

by Biotronics3D, Ltd. 510(k)

Active United States

510(k) K063107

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063107 Date27 Oct 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

3Dnet Suite is a software-based medical image processing system designed to operate on off-the-shelf hardware with a Windows operating system. It functions as a cloud-native platform that provides IHE compliant integration and modular solutions for medical imaging.

This device is identified by FDA 510(k) number K063107. It is a software application developed by Biotronics3D, Ltd. and is categorized under the radiology advisory committee.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the 3Dnet Suite?

    3Dnet Suite is a cloud-native software application designed for medical image processing. It provides IHE compliant integration and modular solutions to support clinical imaging workflows.

  • What hardware requirements are necessary to run 3Dnet Suite?

    The software is designed to operate on standard, off-the-shelf hardware that utilizes a Windows operating system, allowing for flexible deployment within a clinical environment.

  • What is the regulatory status of the 3Dnet Suite?

    The 3Dnet Suite is identified by FDA 510(k) number K063107, which was cleared under the radiology advisory committee as a substantially equivalent medical device.