Radiology AI Directory

FDA-cleared profile

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

Authorized purpose: Swoop Portable MR Imaging System is a portable ultra-low-field MR system for point-of-care head imaging in adult and pediatric patients when a conventional full diagnostic MRI examination is impractical.

Neuro MRI
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: Swoop Portable MR Imaging System is a portable ultra-low-field MR system for point-of-care head imaging in adult and pediatric patients when a conventional full diagnostic MRI examination is impractical.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Swoop Portable MR Imaging System is a portable ultra-low-field MR system for point-of-care head imaging in adult and pediatric patients when a conventional full diagnostic MRI examination is impractical.

Evidence takeaway

Evidence from the reviewed source record: K240944 reports system, deep-learning reconstruction, image-quality, safety, and clinical-image validation for the portable head MRI workflow. The public package does not establish classifier sensitivity or specificity and does not replace the interpretation of a qualified physician.

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
Swoop Portable MR Imaging System is a portable ultra-low-field MR system for point-of-care head imaging in adult and pediatric patients when a conventional full diagnostic MRI examination is impractical.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
trained physician
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet identifies a trained physician as the interpreter and does not establish MRI technologists as an intended-user class.

Care setting and population
Hospital, emergency, intensive-care, outpatient, or rehabilitation settings where point-of-care head MRI is appropriate.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Point-of-care head MRI acquisition and reconstruction for professional interpretation when a conventional MRI examination is impractical.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
MRI image data
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet names MRI image data, but does not state the dossier's signal-data, coil, and sequence input wording as a direct device-input claim.

Output and human action
The system can generate MRI data sets with a broad range of contrasts.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet states MRI data sets and DICOM output; it does not state archival output as written in the dossier.

Limitations
The Swoop Portable MR Imaging System is a portable, ultra-low field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This replaces the dossier's unsupported conventional-MRI replacement statement with the packet's indication and interpretation boundary.

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
K240944
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet identifies the anatomical site as Head; the dossier's narrower Brain label is not the packet wording. Controlled directory display reconciled from exact FDA wording: Head -> Brain.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-07-16
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Portable scanner and console workflow with DICOM export to a PACS or workstation; validate identifiers, series labels, image orientation, routing, and archive completion.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K240944; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Portable MRI hardware, control device, console software, and release-specific reconstruction software deployed at the point of care.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K240944; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only trained physicians and mri technologists working within the labeled portable-mr workflow should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use only the cleared head-imaging workflow and supported hardware, coils, sequences, patient populations, and operating conditions; low-field images require professional interpretation and do not replace a conventional diagnostic MRI examination when that examination is available.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K240944; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K240944 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Portable scanner and console workflow with DICOM export to a PACS or workstation; validate identifiers, series labels, image orientation, routing, and archive completion.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use only the cleared head-imaging workflow and supported hardware, coils, sequences, patient populations, and operating conditions; low-field images require professional interpretation and do not replace a conventional diagnostic MRI examination when that examination is available.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use only the cleared head-imaging workflow and supported hardware, coils, sequences, patient populations, and operating conditions; low-field images require professional interpretation and do not replace a conventional diagnostic MRI examination when that examination is available.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSourceSource

Evidence

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
K240944 reports system, deep-learning reconstruction, image-quality, safety, and clinical-image validation for the portable head MRI workflow. The public package does not establish classifier sensitivity or specificity and does not replace the interpretation of a qualified physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K240944 FDA performance package for Swoop® Portable MR Imaging® System

  • DesignManufacturer portable-MR system, reconstruction, image-quality, safety, and clinical-image validation
  • PopulationPediatric and adult point-of-care head MRI applications
  • Scopeexact submission
  • Tested versionSwoop Portable MR Imaging System
  • IndependenceSponsor or vendor study

K240944

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

1 unlinked candidate evidence record is retained for source review and excluded from this evidence display.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K240944 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

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
28Fields reviewed
14Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 0 PubMed and 1 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 0 PubMed and 1 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, fda decision summary packet, 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

  1. FDA K240944: Swoop® Portable MR Imaging® System

    U.S. Food and Drug Administration - Published 2024-07-16 - Accessed 2026-09-19

    Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Swoop deep-learning image reconstruction white paper

    Hyperfine - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

  8. Hyperfine Swoop portable MRI

    Hyperfine - Accessed 2026-09-03

    Scope: productFamilyContext, integration, deployment

  9. Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K240944 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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Swoop® Portable MR Imaging® System

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Swoop Portable MR Imaging System provides ultra-low-field point-of-care head MRI for all ages and includes deep-learning T1, T2, FLAIR, and DWI reconstruction.

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