(123 days)
Not Found
Based on the provided "overview," it's impossible to definitively say whether the device contains an AI model.
Here's why and what information from the overview might hint at it:
-
What We Need: To confirm the presence of an AI model, we'd typically look for phrases like:
- "Utilizes machine learning"
- "Powered by artificial intelligence"
- "Runs on an AI chip/processor"
- Specific names of AI frameworks or libraries being used
- Descriptions of features that are clearly AI-driven (like image recognition, natural language processing, predictive analysis).
-
What the Overview Might Indicate (if present): If the overview includes descriptions of features or capabilities that often rely on AI, it could suggest the presence of an AI model. Examples might include:
- "Smart assistant functionality"
- "Personalized recommendations"
- "Anomaly detection"
- "Advanced pattern recognition"
- "Predictive maintenance"
- Any description of "learning" or "adapting" based on data.
In summary, without the content of the {{overview}}, I cannot answer your question.
Please provide the text from the {{overview}} field so I can analyze it and give you a more informed answer.
No
Explanation: The device is described as an imaging system for producing images to assist in diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images produced by the device, "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis." This indicates that the device aids in the diagnostic process.
Unknown
The summary does not provide enough detail to definitively determine if the device is hardware-only, software-only, or a combination. It mentions "device hardware" and "the device," which could refer to software running on general-purpose hardware, or entirely new dedicated hardware.
To determine if the device described in the overview is an IVD (In Vitro Diagnostic) device, we need to analyze the description and compare it against the definition of an IVD.
Here's a breakdown of the typical definition of an IVD and how to apply it to your overview:
What is an IVD?
Generally, an In Vitro Diagnostic (IVD) medical device is defined by regulatory bodies (like the FDA in the US or the European Union) as:
- A medical device intended by the manufacturer to be used in vitro (outside of the living body). This is a core requirement.
- For the examination of specimens, including blood, urine, tissues, or other body fluids, derived from the human body. This specifies the source of what is being tested.
- For the purpose of obtaining information concerning:
- A physiological or pathological state (e.g., disease diagnosis).
- Congenital physical or mental impairments.
- Predisposition to a medical condition or a disease.
- To determine the safety and compatibility of potential donors and recipients.
- To monitor therapeutic measures.
How to Apply This to Your Overview:
Now, let's look at your {{overview}} and use the definition to determine if it's an IVD:
- Does the device operate in vitro? Read the overview carefully. Does the device test samples that have been removed from the body, rather than performing tests directly on or in the body?
- Does it examine specimens from the human body? What kind of material does the device analyze? Is it blood, urine, tissue, etc.?
- What is the intended purpose of the device? This is crucial. What information is the device designed to provide? Is it for diagnosis, monitoring, screening, compatibility testing, etc.? Look for phrases that indicate the goal of using the device.
Possible Scenarios Based on Your {{overview}}:
- If your overview describes a device that analyzes blood samples to diagnose a specific disease (e.g., diabetes), it is likely an IVD. It operates in vitro, examines a human specimen (blood), and has a diagnostic purpose.
- If your overview describes a device that measures a patient's heart rate using a sensor on their skin, it is not an IVD. It operates in vivo (on the living body), not in vitro.
- If your overview describes a device that analyzes a urine sample to monitor the effectiveness of a drug treatment, it is likely an IVD. It operates in vitro, examines a human specimen (urine), and has a purpose related to monitoring therapeutic measures.
- If your overview describes a laboratory instrument that is used in a process involving human specimens but its primary function is not to provide diagnostic or related information about the human body (e.g., a simple centrifuge used to prepare samples), it might not be classified as an IVD itself, even though it's used in an IVD workflow. The key is its intended purpose.
Conclusion:
Based on the information in your {{overview}}, I will tell you whether the device is an IVD. Please provide the overview.
Once you provide the overview, I will analyze it and provide a direct "Yes" or "No" answer and briefly explain my reasoning based on the criteria above.
N/A
Intended Use / Indications for Use
The Swoop® Portable MR Imaging® System (V2) 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, MOS
Device Description
The Swoop System (V2) is portable, ultra-low field MRI device that enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device that is used for operating the system, providing access to scan orders, exam setup, exam execution, viewing MRI image data for quality control purposes, and PACS interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to preview images. The Swoop System (V2) image reconstruction algorithm utilizes deep learning for optimized image quality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head
Indicated Patient Age Range
Adult and pediatric patients (>= 0 years)
Intended User / Care Setting
At the point of care in professional health care facilities such as emergency rooms, intensive/critical care units, hospitals, outpatient, or rehabilitation centers.
Description of the training set, sample size, data source, and annotation protocol
Not Found. The document states: "Performance analysis and validation of the subject device Advanced Reconstruction models was performed using a test dataset entirely independent from the dataset used for model training."
Description of the test set, sample size, data source, and annotation protocol
Performance analysis and validation of the subject device Advanced Reconstruction models was performed using a test dataset entirely independent from the dataset used for model training. The test dataset comprises a total of 58 individual subjects and 313 unique images collected using sequence types available on the subject device. For each subject, a subset of the following sequences, chosen appropriately for the indication for imaging, was scanned: T1 Gray-White, T1 Standard, T2, T2 Fast, FLAIR, FLAIR Fast, DWI, DWI Fast (DWI b=0, b=900, ADC). Axial, Sagittal, and Coronal orientations were included; for DWI sequences, only Axial was available. A description of the acceptance criteria and subset of data used for each test is included in the test summaries below.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Advanced Reconstruction Performance Analysis and Validation
- Study Design: Advanced Reconstruction was assessed for robustness, stability, and generalizability over a variety of subjects, design parameters, artifacts, and scan conditions using reference-based metrics. A set of images including Swoop data, high field images, and synthetic contrast images, was used as ground truth target images. Test input data (synthetic k-space generated from the target images) was reconstructed using both Advanced and Linear Reconstruction, and the similarity to the original ground truth image was compared between the two reconstruction methods. Reconstruction outputs with motion and zipper artifacts were qualitatively assessed.
- Sample Size:
- T1, T2, FLAIR group: 40 patients, 111 images.
- DWI group: 29 patients, 94 images.
- Key Metrics: Normalized mean squared error (NMSE) and structural similarity index (SSIM).
- Key Results: For all models and all test datasets, NMSE was reduced and SSIM was improved for Advanced Reconstruction test images compared to Linear Reconstruction test images. Advanced Reconstruction preserved the presentation of motion and zipper artifacts, and no unexpected output was observed.
2. Contrast-to-Noise Ratio Validation
- Study Design: Regions of interest (ROI) encompassing pathologies were annotated and reviewed by two American Board of Radiology (ABR) certified radiologists. The contrast-to-noise of hyper- and hypo- intense pathologies were measured with respect to healthy white matter tissue from the same image. The inclusion criterion for images used for this study was at least one visible pathology.
- Sample Size: 15 patients, 46 images, 58 pathologies, 464 ROIs. A minimum of 16 images per model type (sequence group) were included for lesion annotation.
- Key Metrics: Contrast-to-Noise Ratio (CNR).
- Key Results: In all cases, CNR of Advanced Reconstruction was greater than or equal to Linear Reconstruction for both hyper- and hypo-intense pathologies. The study result demonstrates that Advanced Reconstruction does not unexpectedly modify, remove, or reduce the contrast of pathology features.
3. Advanced Reconstruction Image Validation
- Study Design: Five external, ABR-certified radiologists representing clinical users were asked to review side-by-side clinical image sets taken with the subject Swoop System, reconstructed with both Advanced and Linear Reconstruction. The reviewers rated the images using a five-point scale for image quality and the consistency of diagnosis using both methods in the categories of noise, sharpness, contrast, geometric fidelity, artifact, and overall image quality.
- Sample Size: 32 patients, 167 images. A sample size of at least 16 was used per sequence. Within the sample dataset at least four cases for each sequence-available image orientation (axial, sagittal, coronal) were used.
- Key Metrics: Five-point Likert scale for image quality and consistency of diagnosis.
- Key Results: Advanced Reconstruction achieved a median score of 2 (the most positive rating scale value) in all categories. This scoring indicates reviewers found Advanced Reconstruction improved image quality while maintaining diagnostic consistency relative to Linear Reconstruction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Normalized mean squared error (NMSE)
- Structural similarity index (SSIM)
- Contrast-to-Noise Ratio (CNR)
- Five-point Likert scale for subjective image quality
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
FDA Clearance Letter for Swoop® Portable MR Imaging® System (V2)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
May 30, 2025
Hyperfine, Inc.
Christine Kupchick
Sr. Manager, Global Regulatory
351 New Whitfield St
Guilford, Connecticut 06437
Re: K250236
Trade/Device Name: Swoop® Portable MR Imaging® System (V2)
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic Resonance Diagnostic Device
Regulatory Class: Class II
Product Code: LNH, MOS
Dated: May 7, 2025
Received: May 7, 2025
Dear Christine Kupchick:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K250236 - Christine Kupchick Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K250236 - Christine Kupchick Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel M. Krainak, Ph.D.
Assistant Director
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
Device Name
Swoop® Portable MR Imaging® System (V2)
Indications for Use (Describe)
The Swoop® Portable MR Imaging® System (V2) 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.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
Swoop® Portable MR Imaging® System (V2)
K250236
510(K) SUBMITTER
Company Name: Hyperfine, Inc.
Company Address: 351 New Whitfield St
Guilford, CT 06437
CONTACT
Name: Christine Kupchick
Telephone: (203) 343-3404
Email: ckupchick@hyperfine.io
Date Prepared: May 22, 2025
DEVICE IDENTIFICATION
Trade Name: Swoop® Portable MR Imaging® System (V2)
Common Name: Magnetic Resonance Imaging
Regulation Number: 21 CFR 892.1000
Classification Name: System, Nuclear Magnetic Resonance Imaging Coil, Magnetic Resonance
Product Code: LNH; MOS
Regulatory Class: Class II
PREDICATE DEVICE INFORMATION
The subject Swoop Portable MR Imaging System (V2) is substantially equivalent to the predicate Swoop System (K240944).
Page 6
DEVICE DESCRIPTION
The Swoop System (V2) is portable, ultra-low field MRI device that enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device that is used for operating the system, providing access to scan orders, exam setup, exam execution, viewing MRI image data for quality control purposes, and PACS interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to preview images. The Swoop System (V2) image reconstruction algorithm utilizes deep learning for optimized image quality.
INDICATIONS FOR USE
The Swoop Portable MR Imaging System (V2) 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.
SUBSTANTIAL EQUIVALENCE DISCUSSION
The table below compares the subject device to the predicate.
| Specification | Subject Swoop Portable MR Imaging System (V2) | Predicate Swoop Portable MR Imaging System (V1) (K240944) |
|---|---|---|
| INTENDED USE | ||
| Intended Use/ Indications for Use | 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. | Same |
| Patient Population | Adult and pediatric patients (≥ 0 years) | Same |
| Anatomical Sites | Head | Same |
| Environment of Use | At the point of care in professional health care facilities such as emergency rooms, intensive/critical care units, hospitals, outpatient, or rehabilitation centers. | Same |
| Energy Used and/or delivered | Magnetic Resonance | Same |
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| MAGNET | ||
|---|---|---|
| Field strength | 64.9 mT (nominal) | 63.3 ± 2.0 mT |
| Type | Permanent magnet | Same |
| Patient accessible bore size | 36.0 in. width, 13.4 in. height | 24.0 in. width, 12.4 in. height |
| Magnet weight | 712 lbs. | 705 lbs. |
| GRADIENT SYSTEM | ||
| Maximum gradient amplitude | X: 33.9 mT/m | |
| Y: 33.2 mT/m | ||
| Z: 66.2 mT/m | X: 24.3 mT/m | |
| Y: 22.9 mT/m | ||
| Z: 38.5 mT/m | ||
| Rise time (zero to max) | X: 1.8 ms | |
| Y: 1.8 ms | ||
| Z: 5.1 ms | X: 2.1 ms | |
| Y: 2.0 ms | ||
| Z: 3.8 ms | ||
| Slew rate | X: 18.8 T/m/s | |
| Y: 18.4 T/m/s | ||
| Z: 13.0 T/m/s | X: 24 T/m/s | |
| Y: 22 T/m/s | ||
| Z: 21 T/m/s | ||
| RF COIL | ||
| Type | Transmit/receive | Same |
| Transmit coil design | Linear | Same |
| OTHER | ||
| Patient weight capacity | 1.6kg-200 kg | Same |
| Operation temperature | 15-30 C | Same |
| Warm up time |