CoLumbo C-Spine
by Smart Soft Healthcare Ad Bulgaria EUDAMED510(k)
510(k) K254015 Product code QIH
Overview
The CoLumbo C-Spine is a cervical spine imaging device designed for radiologic assessment of spinal alignment and pathology. It integrates advanced imaging analysis to support diagnostic evaluation of cervical spine conditions, including alignment deviations, degenerative changes, and trauma-related injuries.
This device is supplied as a software-based solution for use in radiology departments, adhering to FDA 510(k) clearance and MDR requirements. It operates as a reusable system, compatible with MRI environments, and is intended for single-user or multi-user clinical workflows. Storage and handling follow standard IT and medical imaging protocols, with no specified sterility requirements due to its non-invasive, software-driven nature.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK254015 | Date1 Apr 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 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
Questions
What clinical conditions is the CoLumbo C-Spine designed to help evaluate in the cervical spine?
The CoLumbo C-Spine is specifically designed to assist in the radiologic assessment of cervical spine alignment and pathology. It supports diagnostic evaluations for conditions such as alignment deviations, degenerative changes (e.g., osteoarthritis or disc degeneration), and trauma-related injuries, providing advanced imaging analysis to aid clinicians in these areas.
Is the CoLumbo C-Spine a single-use or reusable device, and how does that affect its use in clinical settings?
The CoLumbo C-Spine is a reusable software-based system, meaning it is not discarded after a single use. This design allows it to be utilized in both single-user and multi-user clinical workflows, such as radiology departments, without the need for replacement. Its compatibility with MRI environments further expands its utility in settings where imaging flexibility is required.
How should the CoLumbo C-Spine be stored and handled, given its nature as a software-based device?
Since the CoLumbo C-Spine is a non-invasive, software-driven solution, it does not require sterility measures like traditional medical devices. Storage and handling follow standard IT and medical imaging protocols to ensure data integrity and system reliability. This includes adhering to typical IT security and environmental controls for medical imaging systems.
What regulatory pathways does the CoLumbo C-Spine follow, and how does that impact its availability?
The CoLumbo C-Spine has undergone FDA 510(k) clearance and adheres to the Medical Device Regulation (MDR) requirements. These pathways confirm its substantial equivalence to existing devices in the radiology category (product code QIH), ensuring it meets regulatory standards for diagnostic imaging software. Its clearance status supports its availability for clinical use in markets where these regulatory approvals are recognized.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K254015
- EUDAMED