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CoLumboX

by Smart Soft Healthcare Ad Bulgaria 510(k)

510(k) K250367 Product code QIH

Overview

CoLumboX is a medical image management and processing system. It is classified as Automated Radiological Image Processing Software within the QIH product code category.

CoLumboX is supplied as a Class II device under FDA 510(k) clearance K250367. It was determined to be substantially equivalent through a traditional review process by the Radiology advisory committee.

Summary written by AI from registry data, 26 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250367 Date28 May 2025ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Smart Soft Healthcare Ad

  • CoLumboX 2

    Class II

  • CoLumbo 2

    Class II

  • CoLumbo

    Class II

  • CoLumbo C-Spine

    Class II

  • CoLumbo

    Class IIa

Questions

  • What is CoLumboX used for?

    CoLumboX is a medical image management and processing system designed for automated radiological image processing, helping clinicians analyze and manage radiological images more efficiently through software-based automation.

  • How is CoLumboX supplied and what is its regulatory status?

    CoLumboX is supplied as a Class II medical device under FDA 510(k) clearance K250367, determined to be substantially equivalent through a traditional review process by the Radiology advisory committee.

  • Who manufactures CoLumboX and where is it based?

    CoLumboX is manufactured by Smart Soft Healthcare AD, located at 113 General Kolev St., Primorski District, Office 7.2, Varna, Bulgaria, with postal code 9002.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K250367 24 fields · synced 22 Oct 2026