CoLumbo

K220497

Smart Soft Healthcare AD · cleared 2022-06-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“CoLumbo is a medical device (software) for viewing and interpreting magnetic resonance imaging (MRI) of the lumbar spine.”
AlgorithmDeep Convolutional Image-to-Image Neural Network
source quote (p.8)
“Deep Convolutional Image-to-Image Neural Network”
Adaptive (vs locked)No
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.”
PCCPFDA source did not state this
Cybersecurity addressedYes
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: maximum Mean Absolute Error below predetermined allowable error limit; minimum Mean Dice Coefficient above predetermined allowable limit

standards: IEC 62304:2006/AMD 1:2015 Medical device software — Software life cycle processes — Amendment 1, 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 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements, NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

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
1
drift signals on this device
  • 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); 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/K220497