Swoop Portable MR Imaging System

Hyperfine, Inc. • Radiology • 12/06/2022

510(k)IEC 62304 Class B

Device Purpose

The Swoop® Portable MR Imaging System™ is a bedside magnetic resonance device intended for imaging the internal structure of the head when comprehensive diagnostic examinations are clinically impractical. It functions by producing images via magnetic resonance, which, upon interpretation by a trained physician, can provide valuable information useful in determining a diagnosis.

Summary

The Swoop® Portable MR Imaging System™ is a medical device engineered for magnetic resonance imaging directly at a patient's bedside. Its designated purpose is to generate images depicting the internal structure of the human head. This functionality is particularly aimed at clinical contexts where undertaking a comprehensive diagnostic examination with conventional MRI equipment is not feasible or clinically practical. Operating on the principles of magnetic resonance, the system produces visual data of the head's internal anatomy. These images are intended for interpretation by a physician with appropriate training. The information derived from these physician-interpreted images serves as a valuable tool in the diagnostic process, aiding in the determination of a patient's medical condition related to the head.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

SwoopPortable MR ImagingBedside ImagingHead ImagingMagnetic ResonanceDiagnostic InformationPhysician InterpretationInternal Structure (Head)Medical ImagingPoint-of-Care Imaging

Device Metadata

Submission Number

K223247

Company

Hyperfine, Inc.

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Generation

AI Subclass

image enhancement

Relevant Clinical Questions

Q1. What specific image acquisition sequences are supported by the Swoop® system for head imaging?; How does the operational workflow of the Swoop® system at the bedside differ from that of a conventional MRI suite?; What are the limitations in terms of image quality or diagnostic scope when using this portable system compared to standard, high-field MRI for head examinations?; Are there any specific patient populations or conditions for which the use of the Swoop® system is particularly indicated or contraindicated beyond general MRI considerations?; What level of detail regarding the internal structure of the head can be visualized, and how does this correlate with its utility in specific diagnostic scenarios?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score5/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment⚠ Not mentioned in summary

Postmarket Plan⚠ Not mentioned in summary

§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials(operational)

✓ Detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of OBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, ML-BOM, SaaSBOM, HBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.

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