CoLumboX

K250367

Smart 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 segmentation
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. The software automatically initiates measurements resulting from segmentation of the vertebrae and sacrum. Segmentations serve the purpose of calculating measurements.”
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. The user (not the software) controls the threshold for identifying out-of-range measurements.”
PCCPNo
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)

Reader study (MRMC)

n=100 patients

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250367