CoLumbo
K241211Smart Soft Healthcare · cleared 2024-08-15 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation.”
source quote (p.8)
“Deep Convolutional Image-to-Image Neural Network”
source quote (p.10)
“Smart Soft Healthcare conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. The vulnerability assessment and penetration testing demonstrates satisfactory security performance with no critical and high risk vulnerabilities.”
Validation studies (1)
Standalone
n=100 patients
endpoints: accuracy of segmentations and measurements
standards: IEC 62304:2006/AMD 1:2015 Medical device software — Software life cycle processes — Amendment 1, IEC 82304-1:2016 Health software — Part 1: General requirements for product safety, ISO 14971:2019 Medical devices — Application of risk management to medical devices, IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices, ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).