FDA-cleared profile
Hyperfine, Inc.
Authorized purpose: Swoop Portable MR Imaging System V2 is a portable ultra-low-field MR system for head imaging in adult and pediatric patients, including neonates, at the point of care when a conventional full diagnostic MRI examination is impractical.
Product overview
Authorized purpose: Swoop Portable MR Imaging System V2 is a portable ultra-low-field MR system for head imaging in adult and pediatric patients, including neonates, at the point of care when a conventional full diagnostic MRI examination is impractical.
Overview status: Source-reviewed overview
Clinical role: Swoop Portable MR Imaging System V2 is a portable ultra-low-field MR system for head imaging in adult and pediatric patients, including neonates, at the point of care when a conventional full diagnostic MRI examination is impractical.
Evidence from the reviewed source record: K250236 reports an independent performance dataset of 58 subjects and 313 images, pathology and contrast-to-noise testing in 15 patients with 46 images and 58 pathologies, and a three-site image-validation set of 32 patients and 167 images read by five ABR-certified radiologists. The reported CNR was at least as high as linear reconstruction; the public package does not establish classifier sensitivity or specificity.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The packet states the trained-physician interpretation and operator functions but does not state the current MRI-technologist qualification.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
This removes the unsupported claim that the device does not replace conventional MRI when that examination is available.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Current vendor materials are product-family evidence for K250236; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K250236; confirm the exact cleared version, enabled options, deployment, and local compatibility.
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.
Current vendor materials are product-family evidence for K250236; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K250236 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
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 2026-09-03Test 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.
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 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
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 2026-09-03Revalidate 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.
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.
Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
58 subjects
313 images
15 patients
3 sites
5 readers
K250236
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
1 unlinked candidate evidence record is retained for source review and excluded from this evidence display.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
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
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, input, output, intendedUsers, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: integration, deployment, monitoring, productFamilyContext
Scope: productFamilyContext, integration, deployment
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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Hyperfine, Inc.
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.