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Nubex

by Techheim Co., Ltd.

510(k) K211480

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211480 Date8 Jul 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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.

NubeX is a medical image management and processing system designed for the transfer and storage of medical image data generated by various modalities. It functions as a cloud-based PACS system to facilitate the management and accessibility of diagnostic imaging information.

This system is intended to support enterprise-level operations by enabling data sharing across multiple hospital branches and providing remote access to medical images. The device is regulated under 21 CFR 892.2050 and has received FDA 510(k) clearance.

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 NubeX system?

    NubeX is a cloud-based Picture Archiving and Communication System (PACS) designed for the transfer, storage, and management of medical image data from various diagnostic modalities.

  • How does NubeX support multi-site hospital operations?

    The system is designed to support enterprise-level operations by enabling the sharing of diagnostic imaging data across multiple hospital branches and providing remote access to medical images.

  • What is the regulatory status of the NubeX system?

    NubeX is regulated under 21 CFR 892.2050 and has received FDA 510(k) clearance under the K211480 submission, confirming it is substantially equivalent to existing medical image management systems.