CoLumboX
K250367Smart Soft Healthcare AD · cleared 2025-05-28 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“CoLumboX is a medical device (software) for viewing and interpreting radiograph (x-ray) images of the lumbar spine.”
Algorithmrule-based algorithms and thresholds set by each software user
source quote (p.6)
“The measurements are classified using “modifiers” based on rule-based algorithms and thresholds set by each software user and stored in the user's individualized software settings.”
Adaptive (vs locked)No
source quote (p.6)
“The measurements are classified using “modifiers” based on rule-based algorithms and thresholds set by each software user and stored in the user's individualized software settings.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.9)
“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 demonstrate satisfactory security performance with no critical and high-risk vulnerabilities.”
Validation studies (1)
Standalone
n=100 patients
endpoints: accuracy of segmentations; accuracy of measurements
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
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
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).