VINT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. October 15, 2024 Mediimg Corporation % Miso Choi Regulatory Affairs Specialist Mediguide. Inc. #410, Mcluster Bldg., 17, Deogan-ro 104beon-gil Gwangmyeong-si, Gyeonggi-do 14353 Korea, South Re: K240385 Trade/Device Name: VINT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 5, 2024 Received: September 5, 2024 Dear Miso Choi: 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. 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" {1}------------------------------------------------ (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 OS 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 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-reportingcombination-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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, D Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240385 Device Name VINT Indications for Use (Describe) VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format). It enables: - Importing DICOM-compliant MR Images. - Quantitative analysis of imported images. - Visualization and analysis of blood flow characteristics of cerebral arteries in MR images. - Advanced correction options such as offset correction, background phase correction, and anti-aliasing. - Data visualization as a graph or output as an image or numerical data. - Providing the right and left carotid arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA. VINT is intended for use with adult (22 years or more) populations who can undergo MRA. | Type of Use (Select one or both, as applicable) | <table><tr><td> Depurative Use (Part 21 CFR 201.Subpart D) </td><td> Cosmetic Use (Part 21 CFR 201.Subpart D) </td></tr></table> | Depurative Use (Part 21 CFR 201.Subpart D) | Cosmetic Use (Part 21 CFR 201.Subpart D) | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------| | Depurative Use (Part 21 CFR 201.Subpart D) | Cosmetic Use (Part 21 CFR 201.Subpart D) | | | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 510(k) Summary K240385 September 5, 2024 #### Submitter Information & Contact Person 1. | Name of Manufacturer | Mediimg Corp. | |----------------------|-------------------------------------------------------------------------------------------------------------------| | Address | Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si,<br>Gyeonggi-do, Republic of Korea (Zip : 13605) | | Contact Name | Byeong-Uk Jeon / R&D manager | | Telephone No. | +82-10-9011-9694 | | Email Address | RND_jeon@mediimg.com | #### 2. Trade Name, Common Name, Classification Common name: Cerebrovascular imaging software Trade name: VINT | Regulation Description | 21 CFR Section | Product Code | |------------------------------------------------|----------------|--------------| | Medical image management and processing system | 892.2050 | LLZ | As stated in 21 CFR parts 892.2050, devices of this type have been classified as Class II. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for MEDIIMG. The logo features a stylized letter 'M' in blue, with two orange circles above the two vertical lines of the 'M'. The word "MEDIIMG" is written in a sans-serif font below the symbol. Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) Identification of Predicate Device The identified predicate devices and reference device within this submission are shown as follow: ## Predicate device A 3. | 510(k) Number | K172803 | |-----------------|------------------------------------------------| | Applicant | Infinitt Healthcare Co.,Ltd. | | Regulation Name | Medical image management and processing system | | Product code | LLZ | | Device Name | Infinitt PACS 7.0 | # Predicate device B | 510(k) Number | K222854 | |-----------------|------------------------------------------------| | Applicant | Cardio Flow Design Inc. | | Regulation Name | Medical image management and processing system | | Product code | LLZ | | Device Name | iTFlow | # Reference device | 510(k) Number | K213583 | |-----------------|-------------------------------------------------------------------------------| | Applicant | Philips Medical Systems Nederland B.V. | | Regulation Name | Magnetic resonance diagnostic | | Product code | LNH | | Device Name | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for MEDIIMG. The logo features two stylized figures connected at the shoulders, forming a shape resembling the letter 'M'. The figures are colored with an orange gradient at the top, transitioning to a blue gradient at the bottom. Below the figures, the text "MEDIIMG" is written in a simple, sans-serif font. Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) ## 4. Description of the Device ## 4.1. General description VINT is a standalone medical software device designed for processing, analyzing, viewing, and quantifying cerebral artery MR images. The software is intended to visualize and quantify MRI data imported in DICOM format. The key functions of the VINT software are 2D and 3D viewing, multiphase series support, zoom, pan, window level, rotate, ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations, provide heatmaps to help users understand the distribution of arterial signal intensity gradient at a glance, and show measured numbers in a table. VINT is intended for use with adult (22 years or more) populations who can undergo MRA. It can also be used to analyze multi-slice signal intensity gradient of a TOF-MRA to visualize and analyze the blood flow characteristics of cerebral arteries, without any-contrast medium for MR angiography. Medical data (patient information, etc.) is not sent over communication channels and is used only locally. Nevertheless, use network firewall and antivirus software to prevent patient information leakage. ## 4.2. Key Performance Specifications The key functions of the VINT software are 2D and 3D viewing, multi-phase series support, zoom, pan, window level, rotate, ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations, provide heatmaps to help users understand the distribution of arterial signal intensity gradient at a glance, and show measured numbers in a table. ## 4.3. Quantitative imaging function | Contents | Operational Environment | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | · Equation | · $SIG = (Φb - Φa) / Xb - Xa $<br>· Φa, signal intensity at wall point A [Xa], Φb, signal intensity at inner-wall point B [Xb] | | · Output | · Set of real values<br>· Unit: $Signal intensity(SI)/mm$ | | · SIG value (Output) display | · Provided at wall point A [Xa] | | · Resolution | · Same as TOF-MRA (the number of pixels within a specified Field of View (FOV) | | · validation | · 2D PC-MR velocity gradient | | · Level of automatism | · Semi-automatic | | · Iso-value setting for<br>segmentation | · Semi-automatic segmentation: the threshold segmentation method by binary algorithm<br>(default)<br>· Manual setting | 1) Information on signal intensity gradient (SIG) {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo for a company called MEDIIMG. The logo features a stylized letter "M" in blue, with two orange circles on top of the letter. The circles are positioned to resemble the heads of two people standing side by side. The company name, "MEDIIMG," is written in a sans-serif font below the letter "M". Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 2) Information on artery degree of angle | Contents | Operational Environment | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Equation | • The coordinates at the ends of the region of interest are denoted as C1 = (x1, y1, z1), C2 = (x2, y2, z2), The differences between these coordinates are calculated as X = x2 - x1, Y = y2 - y1, Z = z2 - z1.<br>A total of 6 pairs of coordinates, spaced 60 degrees apart, are used.<br>$Angle = \frac{arccos(\frac{Z}{\sqrt{X^2 + Y^2 + Z^2}}}) * 180}{\pi}$ • This process is repeated for each frame in the region of interest. | | • Output | • A real value<br>• Unit: degree | | • Angle (Output) display | • Angle of the region of interest | | • validation | • Comparison with Predicate device Infinitt PACS | | • Level of automation | • Semi-automatic | | • Thresholding methods | • Vessel segmentation: Thresholding based on binarization algorithms<br>• The threshold is automatically determined through image analysis. (default)<br>• Manual threshold setting is also possible. | | • Iso-value setting for<br>segmentation | • Semi-automatic segmentation: Separate the background area and vessels using<br>a binarization algorithm based on image pixel value distribution. The threshold<br>is automatically determined through image analysis. (default)<br>• Manual threshold setting is also possible. | ## 3) Information on coordinate system | Contents | Operational Environment | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Equation | • World Position =<br>• X = Xx * i + Yx * j + Sx<br>• Y = Xy * i + Yy * j + Sy<br>• Z = Xz * i + Yz * j + Sz<br>• (X, Y, Z) : World coordinate system<br>• (i, j) : Pixel coordinates within the image<br>• (Xx, Xy, Xz) : X-direction vector<br>• (Yx, Yy, Yz) : Y-direction vector<br>• (Sx, Sy, Sz): image position (patient)<br>This transformation utilizes DICOM tag information:<br>Image Position (Patient) (0020,0032): (Sx, Sy, Sz)<br>Image Orientation (Patient) (0020,0037): (Xx, Xy, Xz, Yx, Yy, Yz)<br>Pixel Spacing (0028,0030): Pixel size<br>• Length = $\sqrt{(X2 – X1)^2 + (Y2 – Y1)^2 + (Z2 − Z1)^2}$ | | • Output | • World Position: Real-world coordinates<br>• Length: A real value, Unit: mm | | • Output display | • Output information for each point | | • Validation | • Comparison with Predicate device Infinitt PACS | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo for MEDIIMG. The logo features a stylized letter "M" in teal, with two orange circles above the letter. The circles are positioned to resemble the heads of two people. The text "MEDIIMG" is written in a sans-serif font below the letter "M". | Contents | Operational Environment | |------------------------|----------------------------------------------------------------------| | • Level of automation | • Semi-automatic | | • Thresholding methods | • Vessel segmentation: Thresholding based on binaryzation algorithms | Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for MEDIIMG. The logo features a stylized letter 'M' in blue, with two orange circles above the two peaks of the 'M'. The letter 'M' is designed to resemble two people standing side-by-side, with the circles representing their heads. Below the symbol is the text "MEDIIMG" in a simple sans-serif font. Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 4. Indications for Use VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format). It enables: - Importing DICOM-compliant MR Images. - Quantitative analysis of imported images. - Visualization and analysis of blood flow characteristics of cerebral arteries in MR images. - Advanced correction options such as offset correction, background phase correction, and antialiasing. - Data visualization as a graph or output as an image or numerical data. - Providing the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA. VINT is intended for use with adult (22 years or more) populations who can undergo MRA. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a logo for a company called MEDIIMG. The logo features a stylized letter 'M' in blue, with two orange circles on top of the letter. The circles are positioned to resemble the heads of two people, suggesting a focus on individuals or collaboration. The company name, 'MEDIIMG,' is written in a simple, sans-serif font below the letter 'M'. Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 5. Determination of Substantial Equivalence | Sort | Proposed Device | Predicate Device A | Predicate Device B | Reference Device | SE<br>Decision | |----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | Device<br>Name | VINT | Infinitt PACS 7.0 | iTFlow | Achieva, Ingenia, Ingenia<br>CX, Ingenia Elition and<br>Ingenia Ambition MR<br>Systems | - | | 510(k)<br>Number | - | K172803 | K222854 | K213583 | - | | Classific<br>ation | Same | Class II | Class II | Class II | - | | Regulati<br>on<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1000 | - | | Regulati<br>on<br>Name | Medical image management<br>and processing system | Medical image management<br>and processing system | Medical image management<br>and processing system | Magnetic resonance<br>diagnostic | - | | Product<br>Code | LLZ | LLZ | LLZ | LNH | - | | Intended<br>Use | VINT is a software that<br>allows for the viewing, post-<br>processing, and quantitative<br>evaluation of cerebrovascular<br>MRI data (in DICOM-<br>compliant format).<br>It enables:<br>- Importing DICOM-<br>compliant MR Images.<br>- Quantitative analysis of<br>imported images.<br>- Visualization and analysis of<br>blood flow characteristics of<br>cerebral arteries in MR<br>images.<br>- Advanced correction options<br>such as offset correction,<br>background phase correction,<br>and anti-aliasing.<br>- Data visualization as a graph<br>or output as an image or<br>numerical data.<br>- Providing the right and left<br>carotid and vertebral arteries<br>wall signal intensity gradient<br>(SIG), an image-based<br>indirect marker for velocity<br>gradient from TOF-MRA.<br>VINT is intended for use with<br>adult (22 years or more)<br>populations who can undergo<br>MRA | Infinitt PACS 7.0, is a<br>software device that<br>receives medical images<br>and data from various<br>imaging sources. Images<br>and data can be stored,<br>communicated, processed,<br>and displayed within the<br>system or across computer<br>networks at distributed<br>locations.<br>Only preprocessed DICOM<br>for presentation images can<br>be interpreted for primary<br>image diagnosis in<br>mammography. Lossy<br>compressed mammographic<br>images and digitized film<br>screen images must not be<br>reviewed for primary image<br>interpretations.<br>Mammographic images<br>may only be interpreted<br>using a monitor that meets<br>technical specification<br>identified by FDA.<br>Typical users of this system<br>are trained professionals,<br>e.g. physicians, radiologists,<br>nurses, and medical<br>technicians. | The iTFlow software will be<br>utilized in situations where<br>visualization of blood flow<br>in a heart and its major<br>vessels are required for a<br>cardiac diagnosis. iTFlow<br>allows for the viewing, post-<br>processing, and the<br>quantitative evaluation of<br>cardiovascular MRI data (in<br>DIRECTOR-compliant<br>format)<br>It enables:<br>- The import of DICOM-<br>compliant MR Images.<br>- The support of a clinical<br>diagnosis by the quantitative<br>analysis of the imported<br>images.<br>- Quantitative measurement<br>of the size, area, blood flow,<br>volume and mass of the<br>heart and adjacent vessels.<br>-Advanced correction<br>options such as offset<br>correction, background<br>phase correction, and anti-<br>aliasing.<br>-Data visualization as a<br>graph or output as an image<br>or numerical data.<br>iTFlow software will assist<br>clinicians with proper<br>training in cardiac treatment<br>decision making and in<br>providing a conclusive<br>diagnosis for patients. It is<br>intended to analyze<br>cardiovascular MRI image<br>data, that are acquired via | Philips Magnetic Resonance<br>(MR) systems are Medical<br>Electrical Systems indicated<br>for use as a diagnostic<br>device. This MR system<br>enables trained physicians<br>to obtain cross-sectional<br>images, spectroscopic<br>images and/or spectra of the<br>internal structure of the<br>head, body or extremities, in<br>any orientation, representing<br>the spatial distribution of<br>protons or other nuclei with<br>spin.<br>Image appearance is<br>determined by many<br>different physical properties<br>of the tissue and the<br>anatomy, the MR scan<br>technique applied, and<br>presence of contrast agents.<br>The use of contrast agents<br>for diagnostic imaging<br>applications should be<br>performed consistent with<br>the approved labeling for<br>the contrast agent.<br>The trained clinical user can<br>adjust the MR scan<br>parameters to customize<br>image appearance,<br>accelerate image acquisition<br>and synchronize with the<br>patient's breathing or<br>cardiac cycle.<br>The systems can use<br>combinations of images to<br>produce physical<br>parameters, and related | Similar | | | | | | | | | Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) | acquisition, gradient echo cine sequence, and phase contrast time-resolved multi-slice sequence, without any-contrast medium for MR angiography. Patient populations are not restricted. | | spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy determined physical parameters depends on system and scan parameters, and must be controlled and validated the clinical user. In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy. to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user. | | | | Areas of Use | Radiology | Radiology | Radiology | Radiology | Same | | Data Source | TOF-MRA | TOF-MRA, PC-MR, MRI | TOF-MRA, PC-MR (4D Flow) | TOF-MRA, PC-MR, MRI…