Authorized purpose: 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 replacement.
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
Authorized purpose: 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 replacement.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: 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 replacement.
Which images or clinical context are in scope?Modality: MRI Anatomy or clinical context: Spine Input: DICOM 3D gradient-echo MRI images acquired using a dedicated MRI protocol.
Who uses it?Intended users: Imaging experts such as radiologists or orthopedic surgeons.
What does the software produce?Output: DICOM BoneMRI images for viewing in regular DICOM-compatible medical imaging software, with enhanced pelvic and L3-S1 lumbar bone contrast that co-exists with the original images.
What is its most important limitation?Key limitation: Not for diagnosis or monitoring of primary or metastatic tumors; BoneMRI images are not intended to replace CT. Notified or generated images require interpretation with the original study and other clinical information.
Clinical takeaway
Clinical role: 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 replacement.
Evidence takeaway
Evidence from the reviewed source record: K230197 BoneMRI v1.6 was quantitatively validated with paired BoneMRI and CT images from 101 pelvic and 103 lumbar-spine patients. The FDA summary reports acceptance bounds, not exact aggregate point estimates.
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 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 replacement.
Physician-office and clinic or hospital MRI/PACS workflows; the exact submission describes pelvic and lumbar-spine use without a broader care-setting restriction.
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 regular DICOM-compatible medical imaging software, with enhanced pelvic and L3-S1 lumbar bone contrast that co-exists with the original images.
Not for diagnosis or monitoring of primary or metastatic tumors; BoneMRI images are not intended to replace CT. Notified or generated images require interpretation with the original study and other clinical information.
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 service. The FDA summary states that the managed service does not receive protected health information.
FDA source
Exact product version
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-service 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 K230197 v1.6.
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
K230197 BoneMRI v1.6 was quantitatively validated with paired BoneMRI and CT images from 101 pelvic and 103 lumbar-spine patients. The FDA summary reports acceptance bounds, 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; training and validation data were maintained independently and cross-site validation was described.
Population101 patients with pelvic-region data and 103 patients with lumbar-spine data; listed indications included sacroiliitis, hip disease, degenerative spine disease, spondylolisthesis, radiculopathy, spondylosis and spinal fractures.
Scopeexact product version
Tested versionBoneMRI v1.6 release reviewed in FDA submission K230197
Samplen=204
IndependenceIndependence not established
K230197
The FDA summary says 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-version 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-version 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
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