CoLumbo— 510(k) K220497

Substantially Equivalent

Smart Soft Healthcare AD

FDA 510(k) clearance K220497 for CoLumbo, Substantially Equivalent on 2022-06-23. 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: 2022-02-22
Decision date: 2022-06-23
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

K254015 — CoLumbo C-Spine2026-04-01
K250367 — CoLumboX2025-05-28

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