Jazz semi-automatically labels, visualizes, and quantifies segmentable brain structures on MR for patients with known multiple sclerosis and/or brain metastasis, with physician-reviewed/correctable annotations and radiological report output.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
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
Jazz semi-automatically labels, visualizes, and quantifies segmentable brain structures on MR for patients with known multiple sclerosis and/or brain metastasis, with physician-reviewed/correctable annotations and radiological report output.
MR brain images from patients with known multiple sclerosis and/or brain metastasis; preprocessing coregisters images, recognizes contrast, and may pre-annotate abnormalities.
Physician-reviewed labels, visualizations, volumetric measurements, lesion counts/volumes, and an electronic radiological report saved in a user-selected txt, PDF, or DICOM format; the physician may accept, correct, discard, or manually create annotations.
Every pre-annotation and report requires physician review; the exact indication is limited to patients with a known diagnosis of multiple sclerosis and/or brain metastasis; the reviewed packet does not establish use as a general screening or diagnostic substitute.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The FDA comparison describes DICOM-compatible input/output, off-the-shelf hardware, and use by trained professionals in hospitals, imaging centers, or image-processing labs; exact local interface and routing configuration require confirmation.
The exact packet establishes off-the-shelf hardware compatibility but does not establish a current cloud, on-premise, or hosting-region deployment model.
Security and privacy
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
The reviewed sources do not establish a scoped security audit, certification, or control set.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Training, credentialing, and implementation support terms were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Current post-deployment monitoring and change-control practices were not established.
DICOM-compatible physician-controlled reporting
The exact submission supports DICOM-compatible MR workflow, physician review/correction of pre-annotations, and user-selected txt, PDF, or DICOM report/image output.
AI Medical's official Jazz page describes single-click annotation, automatic report generation, longitudinal lesion re-identification, and quantitative follow-up views; the current page is family context and is not used to assign exact K223659 performance or deployment.
product family · checked 2026-09-07
Current family workflow context only; exact-version compatibility requires confirmation.
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
FDA performance testing used 344 subject datasets including healthy, multiple sclerosis, and metastasis patients; measured volumes were compared with manually labeled ground truth, reproducibility used test-retest data, and all reported acceptance criteria passed.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Jazz accuracy and reproducibility validation
DesignRetrospective accuracy and test-retest reproducibility validation against manually labeled ground truth
Population344 subject datasets including healthy subjects, multiple sclerosis patients, and metastasis patients.
Scopeexact submission
Tested versionJazz submitted in K223659; build not stated
Samplen=344
IndependenceIndependence not established
K223659
The FDA reports that all predefined acceptance criteria passed, but the summary provides thresholds rather than observed sensitivity, specificity, Dice, or reproducibility estimates. Training images were segregated from the test set; independent investigators or sponsorship were not established.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
No public amount, range, currency, geography, or contract term was established.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
No payer or CMS policy review was performed in this worker cohort.
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 deployment and data flow: The exact packet establishes off-the-shelf hardware compatibility but does not establish a current cloud, on-premise, or hosting-region deployment model.
Verify security and privacy controls: The reviewed sources do not establish a scoped security audit, certification, or control set.
Verify training: Training, credentialing, and implementation support terms were not established.
Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
Verify local validation and lifecycle monitoring: Current post-deployment monitoring and change-control practices were not established.
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
26Fields reviewed
10Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed, ClinicalTrials.gov, and exact-submission recall metadata candidates were screened by identifier and count. The records were not treated as a full paper, trial, or postmarket review. The current discovery snapshot contains 20 PubMed and 10 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, fda device recall, 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 history7 sources - 2 history items
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