BoneMRI v1.6

K230197

MRIguidance B.V. · cleared 2023-02-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The BoneMRI application is a standalone image processing software application that analyses 3D gradient echo MRI scans acquired with a dedicated MRI scan protocol.”

Algorithmimage enhancement algorithm using convolutional neural network. Original images are enhanced by running them through a cascade of filter banks, where thresholding and scaling operations are applied. Separate neural network-based filters are obtained to assign a Hounsfield Unit (HU) value to a single volume element, based on intensity and contextual information. The parameters of the model were obtained through an algorithm development pipeline.

source quote (p.7)

“MRIguidance software implements an image enhancement algorithm using convolutional neural network. Original images are enhanced by running them through a cascade of filter banks, where thresholding and scaling operations are applied. Separate neural network-based filters are obtained to assign a Hounsfield Unit (HU) value to a single volume element, based on intensity and contextual information. The parameters of the model were obtained through an algorithm development pipeline.”

Adaptive (vs locked)No

source quote (p.7)

“The parameters of the model were obtained through an algorithm development pipeline.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=204 patients

endpoints: accuracy of 3D bone morphology; radiodensity; radiodensity contrast versus co-registered CT scans in terms of voxel-by-voxel HUs and standard deviations around these HU values

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K233030 (decision 2024-03-01) from MRIguidance B.V for a matching device line ("BoneMRI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233030

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).