BoneMRI
K202404MRIguidance B.V · cleared 2021-12-22 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“BoneMRI is an image processing software that can be used for image enhancement in MRI images.”
source quote (p.6)
“MRIguidance software implements an image enhancement algorithm using convolutional neural network.”
Validation studies (1)
Retrospective clinical
n=61 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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K230197 (decision 2023-02-22) from MRIguidance B.V. for a matching device line ("BoneMRI v1.6") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K230197
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).