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.

Clearance details

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

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