CoLumbo C-Spine— 510(k) K254015

Substantially Equivalent

Smart Soft Healthcare AD

FDA 510(k) clearance K254015 for CoLumbo C-Spine, Substantially Equivalent on 2026-04-01. Applicant: Smart Soft Healthcare AD. Device class: 2.

Clearance details

Applicant: Smart Soft Healthcare AD
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-15
Decision date: 2026-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Varna, BG

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Smart Soft Healthcare AD

K250367 — CoLumboX2025-05-28
K220497 — CoLumbo2022-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.