Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
MRI-processing software that creates an added bone-contrast image series for review beside the original scan.
Overview status: Source-reviewed overview
What does this software do?It creates MRI-based images that make bone stand out more clearly from surrounding soft tissue.
Which scans and patients is it intended for?It is for people aged 12 and older who have dedicated 3D MRI of pelvic or spinal bone structures.
Who uses it?Imaging experts, such as radiologists or orthopedic surgeons, use the added image series during review.
What does the software produce, and what must the clinician do?It returns a standard image-file (DICOM) BoneMRI series that can be viewed with the original MRI study. The clinician must interpret both together.
What is its most important limitation?It is not a replacement for CT and is not for diagnosing or monitoring primary or metastatic tumors.
Clinical takeaway
BoneMRI is an added MRI image-processing series for bone visualization. It is reviewed alongside the original MRI, not as a general CT substitute.
Evidence takeaway
The FDA submission describes quantitative validation against paired CT in pelvic and spine patients, with stated acceptance bounds. This is a technical validation measure, not a reported patient-outcome measure.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
MRI-based BoneMRI image enhancement for visualizing pelvic and cervical, thoracic, lumbar and S1 spinal bone structures with CT-like radiodensity contrast; not for tumor diagnosis or monitoring and not a CT replacement.
Standalone MRI image-processing server that creates an adjunctive bone-visualization series while the original DICOM study remains available for standard interpretation.
DICOM BoneMRI images for viewing in a regular DICOM-compatible viewer, with 3D bone morphology, tissue radiodensity and tissue-radiodensity contrast visualized alongside the original images.
Not for diagnosis or monitoring of primary or metastatic tumors; BoneMRI images are not intended to replace CT in general. Clinicians must interpret the enhanced images with the original study.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
These links identify a sourced product-family relationship. They do not transfer evidence, metrics, clearance scope, compatibility, pricing, or availability between submissions.
BoneMRI
This is a documented BoneMRI product-family relationship. Each linked FDA submission remains a separate record with its own intended use, evidence, implementation facts, and limitations.
MRIguidance's official BoneMRI page is a current product-family source. The individual FDA decision materials identify the named submissions below. The family source does not establish feature parity, supersession, or current commercial availability for either submission.
K233030 · 2024-03-01. This is the latest FDA decision date among the mapped records only. It is not a statement that K233030 supersedes K230197.
Latest documented release
No source reviewed for this mapping establishes a current commercial release chronology beyond the individual FDA records.
Current commercial availability
The reviewed materials do not establish current commercial availability or an installed version.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Communicates with a DICOM-compatible imaging archive such as PACS to receive MRI input and return BoneMRI images; regular DICOM viewing software displays the result, while receipt and delivery depend on other software systems.
Server application on clinic or hospital networks, available fully on premises with specific GPU requirements or partly as a managed cloud service. The FDA summary states that on-premise PHI stays within the network and data sent to the managed cloud is de-identified before leaving it.
FDA source
Exact FDA submission
Checked 2026-09-07
Deployment language is from the exact FDA submission; it does not establish a current contracted hosting or security configuration.
The FDA deployment description does not establish formal security controls for a current installed configuration.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Exact deployment and DICOM/PACS path
The FDA summary describes on-premise or partly managed-cloud server deployment and DICOM archive/PACS input and return, with output viewed in regular DICOM software.
MRIguidance's current BoneMRI family page describes 3D CT-like images reconstructed from MRI, forwarding reconstructed images to PACS, and compatibility with major MRI scanners.
product family · checked 2026-09-07
Current family material is buyer-relevant workflow context but does not establish feature parity or release identity for K233030.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
K233030 BoneMRI was validated with paired BoneMRI and CT images from 76 pelvic and 117 spine patients. The FDA summary reports bounds for morphology and radiodensity agreement, not exact aggregate point estimates.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
DesignQuantitative validation using paired BoneMRI and CT images from previously conducted clinical investigations; test data were unseen during development.
Population76 patients with pelvic-region data and 117 patients with spine-region data.
Scopeexact submission
Tested versionBoneMRI release reviewed in FDA submission K233030
Samplen=193
IndependenceIndependence not established
K233030
Validation was conducted by MRIguidance; independent-investigator status was not established.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
No public exact-submission price or procurement terms were reviewed.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
CMS policy research was not performed by this worker; no coverage conclusion is made.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: The FDA deployment description does not establish formal security controls for a current installed configuration.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: No public exact-submission price or procurement terms were reviewed.
Verify reimbursement and coding relevance: CMS policy research was not performed by this worker; no coverage conclusion is made.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
18Screened PubMed leads
2Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials candidate metadata were screened in the exact stored order; this was metadata triage, not full-text paper or registry-record review, and no candidate was promoted. The stored recall query returned no records, so no event was promoted and no absence claim is made. The current discovery snapshot contains 18 PubMed and 2 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history9 sources - 3 history items
MRI-based BoneMRI v1.6 image enhancement for visualizing pelvic and L3-S1 lumbar bone structures with enhanced contrast; not for tumor diagnosis or monitoring and not a CT...
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR)...
SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.