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
BrainInsight
Hyperfine, Inc.
Authorized purpose: Automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images and returns annotated/segmented images, color overlays, and reports.
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: Automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images and returns annotated/segmented images, color overlays, and reports.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images and returns annotated/segmented images, color overlays, and reports.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain Input: Low-field MR images, including AI-reconstructed low-field MR; FDA comparison identifies Hyperfine Swoop FSE MRI with specified protocols.
- Who uses it? Intended users: Physician; broader intended-user class is unknown.
- What does the software produce? Output: Annotated and segmented images, color overlays, morphometric/volumetric results, and reports, including DICOM results.
- What is its most important limitation? Key limitation: Adult population >=18 and specified low-field MR scope; additional FDA limitation text is not stated.
Clinical takeaway
Clinical role: Automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images and returns annotated/segmented images, color overlays, and reports.
Evidence takeaway
Evidence from the reviewed source record: FDA reports separate test data, midline-shift MAE of 1.03 mm (T1) and 0.97 mm (T2), and structure Dice/volume comparisons; sample size and diagnostic sensitivity/specificity are not reported.
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
- Automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images and returns annotated/segmented images, color overlays, and reports.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Physician; broader intended-user class is unknown.
FDA comparison describes the output as being for the physician.
- 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
- Low-field MR images, including AI-reconstructed low-field MR; FDA comparison identifies Hyperfine Swoop FSE MRI with specified protocols.
FDA input and acquisition scope.
- Output and human action
- Annotated and segmented images, color overlays, morphometric/volumetric results, and reports, including DICOM results.
FDA output description.
- Limitations
- Adult population >=18 and specified low-field MR scope; additional FDA limitation text is not stated.
FDA packet scope, with unstated additional limitations left unknown.
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 exact-submission ACR model card explicitly references DICOM and PACS 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-cloud
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.
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 BrainInsight; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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 reports separate test data, midline-shift MAE of 1.03 mm (T1) and 0.97 mm (T2), and structure Dice/volume comparisons; sample size and diagnostic sensitivity/specificity are not reported.
Submission-reported FDA evidence summary.
- 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.
BrainInsight regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K220815
- IndependenceIndependence not established
K220815
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 K220815 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 K220815. 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 K220815 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
24Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 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, 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
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FDA K220815: BrainInsight
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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BrainInsight model card (K220815)
Scope: 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 K220815
Scope: postmarketSafety
Research history
-
K220815 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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