Swoop® Portable MR Imaging® System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 19, 2026 Hyperfine, Inc. Jon Wojculewicz Sr. Manager, Regulatory and Quality Assurance 351 New Whitfield St. Guilford, Connecticut 06437 Re: K262622 Trade/Device Name: Swoop® Portable MR Imaging® System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: July 28, 2026 Received: July 28, 2026 Dear Jon Wojculewicz: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262622 - Jon Wojculewicz 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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- {2} K262622 - Jon Wojculewicz 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262622 | ? | | Please provide the device trade name(s). | | ? | | Swoop® Portable MR Imaging® System | | | | Please provide your Indications for Use below. | | ? | | 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. | | | | Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} HYPERFINE K262622 ## 510(k) Summary Swoop® Portable MR Imaging® System 510(k) SUBMITTER Company Name: Hyperfine, Inc. Company Address: 351 New Whitfield St Guilford, CT 06437 CONTACT Name: Jon Wojculewicz Telephone: (860) 810-7918 Email: jwojculewicz@hyperfine.io Date Prepared: July 28, 2026 DEVICE IDENTIFICATION Trade Name: Swoop® Portable MR Imaging® System Common Name: Magnetic Resonance Imaging Regulation Number: 21 CFR 892.1000 Classification Name: System, Nuclear Magnetic Resonance Imaging Coil, Magnetic Resonance, Specialty Product Code: LNH; MOS Regulatory Class: Class II PREDICATE DEVICE INFORMATION The subject Swoop Portable MR Imaging System is substantially equivalent to the predicate Swoop System (K253489). DEVICE DESCRIPTION The Swoop Portable MR Imaging System is a 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 patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage 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, {5} and navigation icons that allow the operator to control the system and to view imagery. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences. The subject Swoop System described in this submission includes software modifications related to the pulse sequences and the user interface. ### 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. ### SUBSTANTIAL EQUIVALENCE DISCUSSION The table below compares the subject device to the predicate. | Specification | Subject | Predicate | | --- | --- | --- | | | Swoop Portable MR Imaging System | Swoop Portable MR Imaging System (K253489) | | 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 | | Magnet: | | | | Field Strength | Model 1 Swoop System\( 63.3 \pm 2.0 \) mTModel 2 Swoop System\( 64.9 \) mT (nominal) | Same | | Type | Permanent magnet | Same | {6} | Specification | Subject Swoop Portable MR Imaging System | Predicate Swoop Portable MR Imaging System (K253489) | | --- | --- | --- | | Patient accessible bore size | Model 1 Swoop System 24.0 in. width, 12.4 in. height Model 2 Swoop System 36.0 in. width, 13.4 in. height | Same | | Magnet weight | Model 1 Swoop System 705 lbs Model 2 Swoop System 712 lbs | Same | | Gradient System: | | | | Maximum gradient amplitude | Model 1 Swoop System X: 24 mT/m, Y: 23 mT/m, Z: 39 mT/m Model 2 Swoop System X: 33.9 mT/m, Y: 33.2 mT/m, Z: 66.2 mT/m | Same | | Rise Time | Model 1 Swoop System X: 2.1 ms, Y: 2.0 ms, Z: 3.8 ms Model 2 Swoop System X: 1.8 ms, Y: 1.8 ms, Z: 5.1 ms | Same | | Slew Rate | Model 1 Swoop System X: 24 T/m/s, Y: 22 T/m/s, Z: 21 T/m/s Model 2 Swoop System X: 18.8 T/m/s, Y: 18.4 T/m/s, Z: 13.0 T/m/s | Same | | RF Coils: | | | | Coil Type | Transmit/receive | Same | | Coil Design | Linear | Same | | Other: | | | | Patient Weight Capacity | 1.6kg-200 kg | Same | | Operation Temperature | 15-30 C | Same | | Warm Up Time | <3 minutes | Same | | Temperature Control | No | Same | | Humidity Control | No | Same | | Sequences: | | | | T1W sequences | • T1 (Standard), T1 (Gray/White), T1 (Standard ISO) • Advanced Gridding reconstruction | • T1 (Standard), T1 (Gray/White) • Advanced Gridding reconstruction | | T2W sequences | • T2, T2 (Fast), T2 (ISO) • Advanced Gridding reconstruction | • T2, T2 (Fast) • Advanced Gridding reconstruction | | FLAIR sequences | Model 1 Swoop System | Model 1 Swoop System | {7} | Specification | Subject Swoop Portable MR Imaging System | Predicate Swoop Portable MR Imaging System (K253489) | | --- | --- | --- | | | - FLAIR, FLAIR (ISO) - Advanced Gridding reconstructionModel 2 Swoop System - FLAIR, FLAIR (Fast), FLAIR (ISO) - Advanced Gridding reconstruction | - FLAIR - Advanced Gridding reconstructionModel 2 Swoop System - FLAIR, FLAIR (Fast) - Advanced Gridding reconstruction | | DWI sequences | Model 1 Swoop System - Single Direction DWI/ADC - Multi-direction DWI/ADC - Advanced Gridding + FISTAModel 2 Swoop System - Single Direction DWI/ADC - Single Direction DWI/ADC High Res - Multi-direction DWI/ADC - Advanced Gridding + FISTA | Model 1 Swoop System - Single Direction DWI/ADC - Multi-direction DWI/ADC - Advanced Gridding + FISTAModel 2 Swoop System - Single Direction DWI/ADC - Multi-direction DWI/ADC - Advanced Gridding + FISTA | | Image Post-Processing (All sequences) | - Advanced Denoising - Image orientation transform - Geometric distortion correction - Receive coil intensity correction - Advanced Interpolation - ADC/Trace output (DWI) - DICOM output | Same | The subject device and the predicate device have the same intended use, operating principles, and similar technological characteristics. There are minor differences between the subject device and the predicate in pulse sequences. These differences do not raise new questions of safety and efficacy as compared to the predicate. ### NON-CLINICAL PERFORMANCE As part of demonstrating substantial equivalence to the predicate, a risk-based assessment was completed to identify the risks associated with the modifications. Based on the risk assessment, the following testing was performed. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence. | Test | Test Description | Applicable Standard(s) | | --- | --- | --- | | Software Verification | Software verification testing in accordance with the design requirements to ensure that the software requirements were met. | - IEC 62304:2016 - FDA Guidance, "Content of Premarket Submissions for Device Software Functions" | {8} | Image Performance | Testing to verify the subject device meets all image quality criteria. | NEMA MS 1-2008 (R2020) NEMA MS 3-2008 (R2020) NEMA MS 9-2008 (R2020) NEMA MS 12-2016 American College of Radiology standards for named sequences | | --- | --- | --- | | Cybersecurity | Testing to verify cybersecurity controls and management. | FDA Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” | | Software Validation | Validation to ensure the subject device meets user needs and performs as intended. | FDA Guidance, “Content of Premarket Submissions for Device Software Functions” | The following testing was leveraged from the predicate device. Test results from the predicate were used to support the subject device because the conditions were identical or the subject device modifications did not introduce a new worst-case configuration or scenario for testing. | Test | Test Description | Applicable Standard(s) | | --- | --- | --- | | Biocompatibility | Biocompatibility testing of patient-contacting materials. | ISO 10993-1:2018 ISO 10993-5:2009 ISO 10993-10:2010 | | Cleaning/Disinfection | Cleaning and disinfection validation of patient-contacting materials. | FDA Guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” ISO 17664:2017 ASTM F3208-17 | | Safety | Electrical Safety, EMC, and Essential Performance testing. | ANSI/AAMI ES 60601-1:2005/(R)2012 IEC 60601-1-2:2014 IEC 60601-1-6:2013 | | Performance | Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems. | NEMA MS 8-2016 | # ADVANCED RECONSTRUCTION PERFORMANCE ANALYSIS AND VALIDATION Performance analysis and validation of the subject device Advanced Reconstruction models was performed using data acquired and reconstructed with the modified software. Although no changes were made to the Advanced Reconstruction models, the performance analysis and validation testing was performed on the new dataset to assess whether model performance drifted. No images from the test dataset were used for model training. Advanced Reconstruction models are trained only to remove noise and image encoding artifacts and are explicitly prevented from changing image features including pathology. Models are trained with image patches from MRI as well as natural images. While gender and age are available for most subjects, age, gender, ethnic background, and pathology are not expected to influence model architecture or performance. {9} ## Performance Analysis: 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. ### Reference Standard and Metrics: Normalized mean squared error (NMSE) and structural similarity index (SSIM) were used to compare the ability of Advanced Reconstruction to reproduce the ground truth image compared to Linear Reconstruction. ### Dataset and Sample Size: The Swoop test image dataset was fully updated to use images acquired and reconstructed with the modified software, including images with isotropic orientation. None of these test images were used in model training. The demographics of the dataset are shown below. | Patients | 50 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Images | 206 | | | | | | | Demographics and other Variability | Gender: | | | | | | | | Female | | Male | | Unknown | | | | 22% | | 30% | | 48% | | | | Age: | | | | | | | | 0-2 | 2-18 | 18-35 | 35-60 | 60+ | Unknown | | | 0% | 8% | 6% | 8% | 32% | 47% | | | Ethnicity data not recorded. | | | | | | | | Number of sites: 8 | | | | | | | | Equipment type: | | | | | | | | Model 1 Swoop System | | Model 2 Swoop System | | | | | | 55% | | 45% | | | | | | Included pathology: White matter disease, hypertrophic encephalitis, ECMO, intraparenchymal hemorrhage, acute stroke, subacute stroke, subarachnoid hemorrhage, subdural hematoma, hydrocephalus, abnormal cspine, trauma, multiple sclerosis | | | | | | ### Study Results: NMSE and SSIM with the updated dataset were similar to NMSE and SSIM when reconstructing data from previous software versions. 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. {10} ### Contrast-to-Noise Ratio Validation Study Design: Regions of interest (ROI) encompassing pathologies were annotated, and the annotations were reviewed for accuracy by an American Board of Radiology (ABR) certified radiologist. 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. Reference Standard and Metrics: Linear Reconstruction was used as the reference standard for the comparison. Contrast-to-Noise Ratio (CNR) between pathology and healthy tissues was measured to quantify how accurately pathology features are preserved by Advanced Reconstruction. The mean CNR of Advanced Reconstruction was required to be greater than the mean CNR of the baseline Linear Reconstruction at statistical significance level of 0.05 for each sequence type. #### Dataset and Sample Size: 51 images were included for lesion annotation. Inclusion criteria were that the images had at least one visible pathology. The demographics of the dataset are shown below. | Patients | 13 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Images | 51 | | | | | | | ROIs | 162 | | | | | | | Demographics and other Variability | Gender: | | | | | | | | Female | | Male | | Unknown | | | | 41% | | 25% | | 34% | | | | Age: | | | | | | | | 0-2 | 2-18 | 18-35 | 35-60 | 60+ | Unknown | | | 0% | 0% | 0% | 0% | 69% | 31% | | | Ethnicity data not recorded. | | | | | | | | Number of sites: 5 | | | | | | | | Equipment type: | | | | | | | | Model 1 Swoop System | | Model 2 Swoop System | | | | | | 18% | | 82% | | | | | | Included pathology: Acute stroke, Subacute stroke, Multiple Sclerosis, white matter disease, subdural hematoma, subarachnoid hemorrhage, intraparenchymal hemorrhage, hydrocephalus. | | | | | | Study 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 {11} Advanced Reconstruction does not unexpectedly modify, remove, or reduce the contrast of pathology features. ### 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. #### Reference Standard and Metrics: Linear Reconstruction was used as the reference standard for the comparison. Advanced Reconstruction was required to perform at least as well as Linear Reconstruction in all categories (median score \( \geq0 \) on Likert scale) and perform better ( \( \geq1 \) on Likert scale) in at least one of the quality-based categories. #### Dataset and Sample size: 152 images were rated (23 T1, 36 T2, 30 FLAIR, and 19 sets of DWI images. Each DWI set consisted of a b=0, trace-weighted or single direction, and ADC image. The set included 21 isotropic orientation images (5 T1, 5 T2, 11 FLAIR). | Patients | 41 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Images | 152 | | | | | | | Demographics and other Variability | Gender: | | | | | | | | Female | | Male | | Unknown | | | | 20% | | 34% | | 46% | | | | Age: | | | | | | | | 0-2 | 2-18 | 18-35 | 35-60 | 60+ | unknown* | | | 0% | 7% | 7% | 5% | 37% | 44% | | | *anonymized | | | | | | | | Ethnicity data not recorded. | | | | | | | | Number of sites: 6 | | | | | | | | Equipment type: | | | | | | | | Swoop Model 1 | | | Swoop Model 2 | | | | | 39% | | | 61% | | | | | Included pathology: acute stroke, ECMO, encephalomalacia, gliosis, hemorrhagic mass, hydrocephalus, hypertrophic encephalitis, insular infarct, multiple sclerosis, subacute stroke, subarachnoid hemorrhage, subdural hematoma, trauma, white matter disease | | | | | | {12} Test 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. ## CONCLUSION Based on the intended use, technological characteristics, performance results, and comparison to the predicate, the subject Swoop Portable MR Imaging System has been shown to be substantially equivalent to the predicate device identified in this submission and does not present any new issues of safety or effectiveness.