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
AiMIFY (1.x)
Subtle Medical, Inc.
Authorized purpose: Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.
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: Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain Input: T1 pre-contrast and standard-dose T1 post-contrast brain MRI acquired with a GBCA; listed protocols include gradient echo, 3D BRAVO, 3D MPRAGE, 2D T1 spin echo, and T1 FLAIR/inversion recovery at 0.3T, 1.5T, or 3.0T on GE, Philips, Siemens, or Hitachi systems.
- Who uses it? Intended users: Radiologists in an imaging center, clinic, or hospital.
- What does the software produce? Output: Enhanced DICOM MRI image with improved relative CNR, CEP, and LBR; compatible MDDS sends the result to PACS or another DICOM node for clinical review. The software has no GUI and runs in the background.
- What is its most important limitation? Key limitation: Use is tied to standard approved GBCA dosage and supported acquisition protocols. The FDA packet reports increased vessel conspicuity and false-lesion risks, including cases with major diagnostic impact, so enhanced images require radiologist review and should not be treated as an autonomous diagnostic result.
Clinical takeaway
Clinical role: Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.
Evidence takeaway
Evidence from the reviewed source record: FDA K240290 evaluated 95 T1 brain cases, including 57 with lesions, with three board-certified neuroradiologists. Quantitative improvement versus standard post-contrast images was reported for CNR, LBR, and CEP with p < 0.0001; qualitative lesion-visibility endpoints were significantly better and image quality/artifact impact was not worse, also p < 0.0001. Exploratory findings included vessel-conspicuity impact in 11.58% of AiMIFY cases versus 3.51% standard cases and major-impact false lesions in 14% of cases.
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
- Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.
- Intended users
- Radiologists in an imaging center, clinic, or hospital.
- Care setting and population
- Imaging center, clinic, or hospital.
- Workflow role
- Background post-processing image enhancement before radiologist review.
- Required input
- T1 pre-contrast and standard-dose T1 post-contrast brain MRI acquired with a GBCA; listed protocols include gradient echo, 3D BRAVO, 3D MPRAGE, 2D T1 spin echo, and T1 FLAIR/inversion recovery at 0.3T, 1.5T, or 3.0T on GE, Philips, Siemens, or Hitachi systems.
- Output and human action
- Enhanced DICOM MRI image with improved relative CNR, CEP, and LBR; compatible MDDS sends the result to PACS or another DICOM node for clinical review. The software has no GUI and runs in the background.
- Limitations
- Use is tied to standard approved GBCA dosage and supported acquisition protocols. The FDA packet reports increased vessel conspicuity and false-lesion risks, including cases with major diagnostic impact, so enhanced images require radiologist review and should not be treated as an autonomous diagnostic result.
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
- The device receives and returns DICOM images through a compatible MDDS; the enhanced image is sent to PACS or another DICOM node. The device itself does not directly interact with the MR scanner and is described as not networked.
- 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.
Result destination
PACS is explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for AiMIFY (1.x); 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
- FDA K240290 evaluated 95 T1 brain cases, including 57 with lesions, with three board-certified neuroradiologists. Quantitative improvement versus standard post-contrast images was reported for CNR, LBR, and CEP with p < 0.0001; qualitative lesion-visibility endpoints were significantly better and image quality/artifact impact was not worse, also p < 0.0001. Exploratory findings included vessel-conspicuity impact in 11.58% of AiMIFY cases versus 3.51% standard cases and major-impact false lesions in 14% of cases.
- 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.
AiMIFY (1.x) regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K240290
- Samplen=95
- IndependenceIndependence not established
K240290
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 K240290 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 K240290. 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 K240290 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
21Fields reviewed
9Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. 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 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, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, 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
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FDA K240290: AiMIFY (1.x)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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AiMIFY (1.x) model card (K240290)
Scope: intendedUsers, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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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 K240290
Scope: postmarketSafety
Research history
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K240290 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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