CoLumboX

FDA 510(k) K250367 · Smart Soft Healthcare AD

Substantially Equivalent

510(k) numberK250367

Submission

Device name
CoLumboX
Applicant
Smart Soft Healthcare AD
Varna, BG
Received
February 10, 2025
Decision date
May 28, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QIH – Automated Radiological Image Processing Software
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

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K251417ReVISION 2QIH · Traditional Argus Cognitive, Inc.09/09/2026SE
K260525NextMR SpineQIH · Traditional MRI2CT, Inc.09/04/2026SE
K260811Heartvue.ProtonQIH · Traditional Heartvue.ai, Inc.08/26/2026SE
K261595Ceevra Reveal 4QIH · Traditional Ceevra, Inc.08/25/2026SE
K262127DS Core CBCT AnatomyQIH · Traditional Dentsply Sirona08/21/2026SE
K260584BoneMRIQIH · Traditional Mriguidance B.V.08/21/2026SE
K261641Lower Limb AI (LLAI)QIH · Traditional AI Planning Logic, Inc.08/18/2026SE
K253794Prostate CoreQIH · Traditional Lucida Medical, Ltd.08/10/2026SE

More from Lucida Medical, Ltd.

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K254015CoLumbo C-SpineQIH · Traditional 04/01/2026SE
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Questions and answers

When was CoLumboX cleared by the FDA?

CoLumboX (K250367) received a 510(k) decision of Substantially Equivalent on May 28, 2025, 107 days after the submission was received.

What is the product code of K250367?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.