CoLumbo
K220497Smart Soft Healthcare AD · cleared 2022-06-23 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“CoLumbo is a medical device (software) for viewing and interpreting magnetic resonance imaging (MRI) of the lumbar spine.”
source quote (p.8)
“Deep Convolutional Image-to-Image Neural Network”
source quote (p.14)
“The CoLumbo software machine learning algorithm training and testing data used during the algorithm development, as well as validation data used in the U.S. standalone software performance assessment study were all independent data sets.”
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.”
Validation studies (1)
Retrospective clinical
n=101 patients · 7 site(s)
endpoints: measurement accuracy; segmentation accuracy
standards: IEC 62304:2006/AMD 1:2015, ISO 14971:2019, IEC 62366-1:2015+AMD1:2020, ISO 15223-1:2016, NEMA PS 3.1 - 3.20 (2016)
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K241211 (decision 2024-08-15) from Smart Soft Healthcare for a matching device line ("CoLumbo") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241211
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).