Embrace Vision Neonatal MRI System

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 16, 2026 Aspect Imaging, Ltd. % Alex Cadotte Vice President, Digital Health, AI, and Radiology MCRA 803 7th St. NW Washington DC, District of Columbia 20001 Re: K261758 Trade/Device Name: Embrace Vision Neonatal MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: August 14, 2026 Received: August 14, 2026 Dear Alex Cadotte: 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} K261758 - Alex Cadotte 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} K261758 - Alex Cadotte 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. | K261758 | ? | | --- | --- | --- | | Please provide the device trade name(s). | | ? | | Embrace Vision Neonatal MRI System | | | | Please provide your Indications for Use below. | | ? | | The Embrace Vision Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. | | | | Please select the types of uses (select one or both, as applicable). | ☑ 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} [LOGO] aspectimaging 510(k) Premarket Notification Submission 510(k) Summary K261758 Preparation Date: May 26, 2026 Device Trade Name: Embrace Vision Neonatal MRI System Manufacturer: Aspect Imaging LTD 27 Shaked St. Industrial Area Hevel Modi'in Shoham 60850, Israel Contact Person: Yaron Eshel VP, Quality Assurance and Regulatory Affairs Yaron.Eshel@aspectimaging.com Classifications: Magnetic Resonance Diagnostic Device (21 CFR 892.1000) Class: II Product Codes: LNH, MOS Primary Predicate: Embrace Neonatal MRI System (Aspect Imaging, K254277) Page 1 of 4 {5} [LOGO] aspectimaging 510(k) Premarket Notification Submission ## Device Description The Embrace Vision Neonatal MRI System is a 1 Tesla permanent magnet MRI system producing MR images of the neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the procession of the magnetization created by these fields is sampled and processed to produce image data. ## Indications For Use: The Embrace Vision Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. ## Technological characteristics: The subject device, Embrace Vision Neonatal MRI System is intended for the same patient population and anatomical sites as the predicate. The subject device is based on the same principle with modified magnet dimensions adjected gradient while maintaining the same RF coils and patient bed as the predicate device. ## Software: Embrace Vision Neonatal MRI System contains enhancement for usability and strengthened cybersecurity. ## Sequence available to the User: - Spin Echo - 2D Gradient Echo (GRE) - 3D Gradient Echo (GRE) - 2D Time of Flight (TOF) - 3D Time of Flight (TOF) Page 2 of 4 {6} aspectimaging 510(k) Premarket Notification Submission # **Non-clinical performance data:** Safety and efficiency were tested during Verification & Validation in accordance with the below consensus standards (Recognition no. in brackets): Imaging performance: - NEMA MS 1 - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging (12-188) - NEMA MS 12 - Quantification and Mapping of Geometric Distortion for Special Applications (12-306) - NEMA MS 14 - Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems (12-331) - NEMA MS 2 - Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images (12-196) - NEMA MS 3 - Determination of Image Uniformity in Diagnostic Magnetic Resonance Images (12-187) - NEMA MS 5 - Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging (12-322) Safety performance: - NEMA MS 4 - Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices (12-232) - NEMA MS 8 - Characterization of the Specific Absorption Rate (SAR) for MRI Systems (12-315) EMC, Electrical, Mechanical, and Thermal Safety performance: - IEC 60601-1 - Medical equipment/medical electrical equipment - Part 1: General requirements for basic safety and essential performance (19-37) - IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (19-36) - IEC 60601-2-33 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (12-347) - IEC 60601-2-20 - Medical Electrical Equipment Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (6-462) - IEC 60601-1-6 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (5-132) Page 3 of 4 {7} [LOGO] aspectimaging 510(k) Premarket Notification Submission - IEC 62304 - Software life-cycle processes (13-79) ### Biocompatibility: Patient-contacting materials were assessed per FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Patient contact surfaces were classified based on type of contact and duration. All surfaces are considered surface contacting for durations less than or equal to 24 hours. Where required, evidence of testing was provided for endpoints including cytotoxicity, sensitization, and irritation. All patient contact surfaces of the Embrace Vision Neonatal MRI System meet biocompatibility requirements consistent with contact type and duration. ### Human Factors: Embrace Vision Neonatal MRI System is designed similar to other commercially available MRI systems and therefore is familiar and easy to use. Furthermore, the device contains a user-friendly software interface through which the user may easily access all device functions. ### Substantial Equivalence: The subject device, Embrace Vision Neonatal MRI System was demonstrated to be substantially equivalent to the predicate cited above with respect to indications, design materials, function, manufacturing, and performance. The non-clinical tests performed by the company demonstrated that any differences in the Embrace Vision Neonatal MRI System do not raise new questions of safety and effectiveness. ### Conclusion: The subject device, Embrace Vision Neonatal MRI System and the predicate device have the same intended use, have similar technological characteristics, and are made of the same materials. The subject and predicate devices have similar software and EMC characteristics that were validated via new testing. The data included in this submission demonstrates substantial equivalence to the predicate device listed above. The Embrace Vision Neonatal MRI System is as safe, as effective, and performs as well as, or better, than the predicate device. Page 4 of 4