PACS export
Perfusion maps are exported as DICOM images for PACS viewing.
exact submission · checked 2026-09-05FDA-cleared profile
IB NEURO, VERSION 1.0
IMAGING BIOMETRICS, LLC
Post-processing of dynamic brain MRI to generate perfusion maps for trained-physician interpretation.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Post-processing of dynamic brain MRI to generate perfusion maps for trained-physician interpretation.
- Intended users
- Trained physician
- Care setting and population
- Not established in reviewed sources
A specific care setting and age restriction were not established in the reviewed v1.0 summary.
- Workflow role
- Post-processing perfusion analysis
- Required input
- Dynamically acquired MRI datasets from existing MRI systems.
- Output and human action
- Relative cerebral blood volume (rCBV), cerebral blood flow (CBF), mean transit time (MTT) and time-to-peak (TTP) maps; automatic contrast-leakage correction for rCBV, brain masking, normal-appearing white matter normalization and DICOM export to PACS.
- Limitations
- The baseline ACR card lists all scanner manufacturers. This does not establish interoperability with every present-day scanner, sequence or PACS version.
Preserved baseline compatibility statement; current system compatibility requires confirmation.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Exports perfusion parameter maps as DICOM images to PACS for later viewing; supports interactive voxel time curves and arterial-input-function selection.
- Deployment and data flow
- The summary describes an OsiriX plug-in and a platform-independent base library for incorporation into viewing, CAD or PACS applications.
- Security and privacy
- Vendor documentation pending
The 2008 summary does not establish current host security, patch support or a scoped certification for v1.0.
- Training and support
- Vendor documentation pending
Training, supported host versions and current support for legacy v1.0 require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current maintenance and clinical monitoring arrangements for the legacy release were not established.
Legacy host architecture
OsiriX plug-in with a platform-independent base library described for other medical-image applications.
exact submission · checked 2026-09-05Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- K080762 describes nonclinical software verification and validation, with clinical testing listed as not applicable. The later glioma comparison below is family evidence, not a v1.0 validation claim.
- Reported sensitivity
- Not established in reviewed sources
No exact-v1.0 clinical sensitivity estimate was established.
- Reported specificity
- Not established in reviewed sources
No exact-v1.0 clinical specificity estimate was established.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K080762 software verification and validation
Nonclinical software testing summarized for substantial equivalence · Software and perfusion-processing verification; no clinical cohort specified
exact submission · Tested version: IB Neuro v1.0 · Sponsor or vendor studyK080762
Comparison of DSC-MRI Postprocessing Techniques in Predicting Microvascular Histology in Patients with Glioma
Clinical comparison of IB Neuro and nordicICE DSC-MRI postprocessing with histologic subanalyses · 52 glioma patients with 3 T DSC imaging; subanalyses included 25 recurrent glioblastoma patients and 29 biopsies from 12 patients
product family · Tested version: IB Neuro; release not identified in the reviewed abstract · n=52 · Independence not establishedPMID:26359151 · DOI:10.3174/ajnr.A4451
Preload and non-preload analyses and histologic correlations are contextual; subgroup denominators are not a pooled independent cohort and no v1.0 diagnostic metric is inferred.
Economics and lifecycle
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
The reviewed current product page does not establish a v1.0 license, support or upgrade price.
- Reimbursement and coding
- Research pending
No applicable payer policy was reviewed. Current vendor coding links alone do not establish coverage or payment for v1.0.
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
Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
- Verify care setting and population: A specific care setting and age restriction were not established in the reviewed v1.0 summary.
- Verify security and privacy controls: The 2008 summary does not establish current host security, patch support or a scoped certification for v1.0.
- Verify training: Training, supported host versions and current support for legacy v1.0 require vendor confirmation.
- Verify pricing and total cost: The reviewed current product page does not establish a v1.0 license, support or upgrade price.
- Verify reimbursement and coding relevance: No applicable payer policy was reviewed. Current vendor coding links alone do not establish coverage or payment for v1.0.
- Verify local validation and lifecycle monitoring: Current maintenance and clinical monitoring arrangements for the legacy release were not established.
- Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
18Fields reviewed
11Source classes checked
1Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored metadata screened and primary abstract reviewed. Relevant IB Neuro glioma study retained as product-family context; no exact v1.0 linkage or product-wide numeric accuracy claim. The current discovery snapshot contains 1 PubMed and 0 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, acr ai central product, fda decision summary, vendor product page, peer reviewed literature, stored candidate metadata, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-05.
- IB Neuro v1.0: K080762 clearance and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- IB Neuro model card (K080762) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
- IB Neuro current product family Imaging Biometrics · 2026-09-05
- Comparison of DSC-MRI Postprocessing Techniques in Predicting Microvascular Histology in Patients with Glioma American Journal of Neuroradiology / U.S. National Library of Medicine · 2026-09-05
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