Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
RSI-MRI+
MultiModal Imaging Services Corporation (dba HealthLytix)
Authorized purpose: RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.
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: RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Prostate Input: RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging data and optional automated fusion of derived image data with anatomical T2-weighted MR images.
- Who uses it? Intended users: Radiologists, urologists, and other clinicians
- What does the software produce? Output: RSI-MRI+ outputs include: a Restricted Signal Map (enhanced DWI map demonstrating improved conspicuity of restricted diffusion), a Color Fusion Series (overlay of Restricted Signal Map onto T2-weighted images), automated prostate segmentation results (Prostate Segmentation Series), and an Automated Segmentation Report containing segmentation volume and images of the segmented prostate. All outputs are provided in standard DICOM format.
- What is its most important limitation? Key limitation: RSI-MRI+ is not intended for use in pediatric populations. RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions.
Clinical takeaway
Clinical role: RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.
Evidence takeaway
Evidence from the reviewed source record: Software validation was performed to demonstrate that RSI-MRI+ processes DICOM images and presents the processed images and quantitative results in DICOM format. In all instances RSI-MRI+ functioned as intended and outputs were created as expected. Performance testing included increased conspicuity of the Restricted Signal Map, accuracy of automated segmentation compared to manual radiologist segmentations, and diffusion signal normalization across acquisitions and scanners.
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
- RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.
- Intended users
- Radiologists, urologists, and other clinicians
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Segmentation or contouring
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging data and optional automated fusion of derived image data with anatomical T2-weighted MR images.
The exact device description establishes DICOM input, supported protocols, diffusion-weighted MRI, and optional T2-weighted fusion; the current generic and consult-instruction wording is not retained.
- Output and human action
- RSI-MRI+ outputs include: a Restricted Signal Map (enhanced DWI map demonstrating improved conspicuity of restricted diffusion), a Color Fusion Series (overlay of Restricted Signal Map onto T2-weighted images), automated prostate segmentation results (Prostate Segmentation Series), and an Automated Segmentation Report containing segmentation volume and images of the segmented prostate. All outputs are provided in standard DICOM format.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- RSI-MRI+ is not intended for use in pediatric populations. RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions.
The exact indications provide the pediatric and diagnostic-purpose limitations; the packet does not state the current all-scanner-manufacturers wording.
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.
- FDA submission
- K191278
- Modality
- MRI
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Prostate
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2019-11-19
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for RSI-MRI+; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
Performance evidence
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
- Software validation was performed to demonstrate that RSI-MRI+ processes DICOM images and presents the processed images and quantitative results in DICOM format. In all instances RSI-MRI+ functioned as intended and outputs were created as expected. Performance testing included increased conspicuity of the Restricted Signal Map, accuracy of automated segmentation compared to manual radiologist segmentations, and diffusion signal normalization across acquisitions and scanners.
The exact performance section reports DICOM processing validation and the listed performance testing; it does not reduce the packet to the current standalone-performance label.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
RSI-MRI+ regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K191278
- IndependenceIndependence not established
K191278
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
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
No public price or quote for the exact K191278 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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
- The exact-identifier FDA recall query returned no native recall record for K191278. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K191278 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
25Fields reviewed
10Source classes checked
5Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 5 PubMed and 10 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 5 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, fda device recall, literature index, trial registry, fda decision summary packet, 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 history
Source ledger
-
FDA K191278: RSI-MRI+
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, output, input, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
RSI-MRI+ model card (K191278)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K191278
Scope: postmarketSafety
Research history
-
K191278 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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