Who is the manufacturer of Stage?

Spintech, Inc. filed the 510(k) submission for Stage (K223079).

What is the FDA product code for Stage?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Stage?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Stage?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Stage

K223079 · Spintech, Inc. · LNH · Oct 28, 2022 · Radiology

Device Facts

Record ID	K223079
Device Name	Stage
Applicant	Spintech, Inc.
Product Code	LNH · Radiology
Decision Date	Oct 28, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR).

Device Story

STAGE is a post-processing software solution for brain MRI; operates on a client-supplied computer within a virtual machine environment. Inputs: DICOM data from 3D GRE MRI scan protocols. Processing: Software transforms magnitude and phase data into various contrast-enhanced images and quantitative maps (T1, R2*, PD, SWIM, MRA, DIR). New feature: CROWN white noise filtering algorithm improves specific outputs. Outputs: DICOM datasets sent to PACS. Usage: Operated by radiologists in clinical settings to assist in diagnosis. Benefits: Provides enhanced visualization and quantitative data to support clinical decision-making; must be used alongside conventional MR sequences.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical performance testing, including design controls, risk management, unit-level verification, system integration testing, and simulated use validation.

Technological Characteristics

Software-only device; operates on client-supplied hardware (min. 6-core CPU, 16GB RAM). Processes 3D Spoiled GRE MRI data. Features: Filtered phase maps, intensity projection, automatic high-pass filtering, B1 correction, and CROWN white noise filtering. Outputs include quantitative maps (T1, R2*, PD) and qualitative images (SWI, SWIM, MRA, DIR).

Indications for Use

Indicated for brain imaging in patients requiring visualization of brain structures via MR imaging. Must be used by a qualified radiologist in conjunction with at least one conventional MR acquisition (e.g., T2 FLAIR).

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

STAGE (K210843)

Related Devices

K210843 — STAGE · Spintech, Inc. · Jun 29, 2021
K233733 — SyMRI · Syntheticmr AB (Publ.) · Mar 26, 2024
K201616 — SyMRI · Syntheticmr AB · Jul 28, 2020
K181093 — SyMRI · Syntheticmr AB · Jun 12, 2018
K162943 — SyMRI · Syntheticmr AB · Aug 29, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 28, 2022 SpinTech, Inc. % Rana Hachem Management Representative / Business Operations Manager 30200 Telegraph Road Suite 140 BINGHAM FARMS MI 48025 Re: K223079 Trade/Device Name: Stage Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LLZ Dated: September 28, 2022 Received: September 30, 2022 Dear Rana Hachem: 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. For comprehensive regulatory information about medical devices and radiation-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, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K223079 Device Name STAGE #### Indications for Use (Describe) STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR). X 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 Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for SpinTech MRI. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in a sans-serif font. Below the company name is the tagline "from image to insight" in a smaller font size. # K223079 ## 510(k) Summary | Date Prepared: | September 28, 2022 | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | SpinTech, Inc. 30200 Telegraph Road, Suite 140 Bingham Farms, MI 48025 | | Contact: | Rana El Hachem Management Representative / Business Operations Manager SpinTech, Inc. (248) 712-6789 rana@ spintechmri.com | | Proprietary Name: | STAGE | | Common Name: | System, Imaging Processing, Radiological | | Classification Name: | Magnetic resonance diagnostic device | | Regulation Number: | 21 CFR Section 892.1000 | | Classification Code: | LNH / LLZ | | Review Panel: | Radiology | | Substantially Equivalent Devices: | K210843 - SpinTech, Inc. STAGE | #### Device Description: STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client's existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user's current DICOM viewing software. STAGE has been modified from the predicate to include {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is the logo for SpinTech MRI. The logo consists of a blue atom-like graphic on the left, followed by the words "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and its mission. CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate. | STAGE Quantitative Output | Output Methodology | Technical Characteristics Comparison | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | T1 Map Image: T1 Map | STAGE uses a least squares fitting over variable flip angles to quantify T1. Expected Contrast: WM, GM, CSF contrast will appear similar to a conventional T2W scan. Comparable Conventional Scan Contrast: T1W (inverted) | Methodology Unchanged | | R2* Map Image: R2* Map CROWN enabled R2* Map | STAGE uses a least squares fitting over variable echo times to quantify $R2*/T2*$ . The optional CROWN filter is compatible with R2* Map. Expected Contrast: Veins and midbrain GM structures and cortical GM should be bright relative to surrounding tissues. Diamagnetic tissue (major WM tracts, calcifications) should also appear bright. Comparable Conventional Scan Contrast: SWI /SWAN (inverted) | Methodology Unchanged CROWN functionality available for alternate R2* Map output. | | T2* Map Image: T2* Map | STAGE calculates T2* by simply taking the inverse from the quantified R2* result. The optional CROWN filter is compatible with T2*Map. | Methodology Unchanged CROWN functionality available for alternate T2* Map output. | | CROWN enabled T2* Map Image: Brain scan *different patient scans | GM structures and cortical GM should be dark relative to surrounding tissues. Diamagnetic tissue (major WM tracts, calcifications) should also appear dark. Comparable Conventional Scan Contrast: SWI/SWAN | | | PD Map Image: Brain scan | PD maps are quantified from the same variable flip angle calculation as T1 maps, using the intercept rather than the slope of the least squares fit. The optional CROWN filter is compatible with PD Map. | Methodology Unchanged CROWN functionality available for alternate PD Map output. | | CROWN enabled PD Map Image: Brain scan | Expected Contrast: WM, GM, CSF contrast will appear similar to a conventional T2W scan. However veins and midbrain GM structures and cortical GM should be slightly darker relative to surrounding tissues. Comparable Conventional Scan Contrast: PDW | | | Susceptibility weighted image mapping (SWIM) Image: Brain scan SWIM | The SWIM output, also known as QSM in the field, has been widely used and tested in research. The STAGE version uses a weighted average iterative TKD (Threshold-based K-space Domain) approach. The phase data from each echo is unwrapped and then the background fields are removed. As a first pass, the inverse dipole kernel (the fundamental kernel used to reconstruct SWIM images) is defined using a threshold of 0.1 to estimate the ill-posed values. The veins are then thresholded out of this first pass result and their geometry is used to improve the estimation ill-posed values. This process is iterated 4 times to get a SWIM result for each echo. Last a weighted average | Methodology Unchanged | | | echoes to the final SWIM output. Expected Contrast: Veins and midbrain GM structures and cortical GM should be bright relative to surrounding tissues. Diamagnetic tissue (major WM tracts, calcifications) should appear dark. Comparable Conventional Scan Contrast: SWI /SWAN (inverted) | | | STAGE Qualitative Output | | | | T1 Weighted Enhanced (T1WE) Image: T1WE brain scan CROWN enabled T1 Weighted Enhanced (T1WE) Image: CROWN enabled T1WE brain scan *different patient scans | To create enhanced T1W data, STAGE subtracts the PDW input data with negative WM/GM contrast from the T1W input data with positive WM/GM contrast. This is not a synthetic image calculated from the quantitative maps. The optional CROWN filter is compatible with T1WE. Expected Contrast: This output should appear like a conventional T1 weighted anatomical scan. Comparable Conventional Scan: MPRAGE | Methodology Unchanged CROWN functionality available for alternate T1WE output. | | Susceptibility weighted imaging (SWI) | The SWI from STAGE uses the same general process: high-pass filtering the phase data, creating a mask, and applying it to the magnitude data. The optional CROWN filter is compatible with SWI. | Methodology Unchanged CROWN functionality available for alternate SWI output. | | Image: SWI CROWN enabled Susceptibility weighted imaging (SWI) Simulated SWI *different patient scans | Expected Contrast: Veins and midbrain structures should appear dark relative to surrounding tissues. Diamagnetic tissue (major WM tracts, calcifications) should also appear dark. Comparable Conventional Scan: SWI /SWAN | | | True Susceptibility weighted imaging (tSWI) tSWI | True SWI works the same way except using iSWIM data to create a mask, helping eliminate the geometry dependence of the phase data. The optional CROWN filter is compatible with tSWI. Expected Contrast: Veins and midbrain structures should appear dark relative to surrounding tissues. Diamagnetic tissue (major WM tracts, calcifications) should also appear dark. Comparable Conventional Scan Contrast: SWI /SWAN | Methodology Unchanged CROWN functionality available for alternate tSWI output. | | Image: CROWN enabled True Susceptibility weighted imaging (tSWI) Simulated tSWI | | | | *different patient scans | | | | Pseudo SWIM (pSWIM) Image: pSWIM | Pseudo-susceptibility map (pSWIM) is created from an intensity projection of the filtered phase data. The results are not quantitative but provide similar contrast to SWIM. Expected Contrast: Veins and midbrain GM structures and cortical GM should be bright relative to surrounding tissues. Comparable Conventional Scan Contrast: SWI /SWAN MIP (inverted) | Methodology Unchanged | | Modified pSWIM (mpSWIM) Image: mpSWIM | Modified pseudo-susceptibility map (mpSWIM) are created from an intensity projection of the filtered phase data. The results are not quantitative but provide similar contrast to SWIM. Expected Contrast: Veins and midbrain GM structures and cortical GM should be bright relative to surrounding tissues. Highly diamagnetic tissue (calcifications) should appear dark. Comparable Conventional Scan Contrast: SWI /SWAN MIP (inverted) | Methodology Unchanged | | Magnetic resonance angiography (MRA) Image: MRA | The STAGE MRA output uses a maximum intensity projection of the T1W input data to exploit the time of flight effect of the arterial blood. Expected Contrast: Arterial blood flowing into the imaging slab should be bright. Other tissues should show little to no contrast. Comparable Conventional Scan Contrast: TOF MRA | Methodology Unchanged | | Simulated Synthetic dual inversion recovery (DIR) | Any simulated data (e.g., DIR) are created through a forward simulation process using the T1 and PD maps as input. The optional CROWN filter is compatible | Methodology Unchanged | | Image: Brain scan | with simulated DIR. Expected Contrast: For the three DIR outputs, either GM, WM, or CSF alone will be bright and the rest will be dark. Comparable Conventional Scan Contrast: Dual Inversion Recovery | | | Simulated T1W Image: Brain scan | Any simulated data are created through a forward simulation process using the T1 and PD maps as input. Expected Contrast: For the three DIR outputs, either GM, WM, or CSF alone will be bright and the rest will be dark. Comparable Conventional Scan Contrast: Dual Inversion Recovery | Methodology Unchanged CROWN functionality available for alternate simulated T1W output. | | Simulated PDW Image: Brain scan | Any simulated data are created through a forward simulation process using the T1 and PD maps as input. Expected Contrast: For the three DIR outputs, either GM, WM, or CSF alone will be bright and the rest will be dark. Comparable Conventional Scan Contrast: Dual Inversion Recovery | Methodology Unchanged CROWN functionality available for alternate simulated PDW output. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for SpinTech MRI. The logo consists of a blue circular graphic with three orbiting lines on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font size and also in blue. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for SpinTech MRI. The logo features a stylized atom symbol on the left, followed by the text "SpinTechMRI" in a blue sans-serif font. Below the company name is the tagline "from image to insight" in a smaller font size. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font size. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the SpinTech MRI logo. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a stylized atom graphic to the left of the company name. The text "SpinTech" is in a dark blue, and "MRI" is in a lighter blue. Below the company name is the tagline "from image to insight" in a smaller font. #### Indications for Use: STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced TI weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD). {10}------------------------------------------------ Image /page/10/Picture/0 description: The image is a logo for SpinTech MRI. The logo features a blue atom-like graphic on the left, followed by the text "SpinTechMRI" in blue. Below the text, there is a tagline that reads "from image to insight" in a smaller font size. When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR). #### Comparison of Technological Characteristics: The STAGE fundamental technological characteristics are similar to those of the predicate device as noted in the following table. | Characteristic | Predicate Device STAGE (v. 1.1) SpinTech, Inc. (K210843) | Proposed Device STAGE (v 2.0 incl. CROWN) SpinTech, Inc. (TBD) | Similarities and Differences | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | Classification | Class II | Class II | Identical | | Regulation | 21 CFR 892.1000 | 21 CFR 892.1000 | Identical | | Regulation Name | Magnetic resonance diagnostic device | Magnetic resonance diagnostic device | Identical | | Product Code | LNH LLZ | LNH LLZ | Identical | | Prescription | Rx only | Rx only | Identical | | Indications for Use | STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. | STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. | Identical | | | STAGE is indicated for brain | STAGE is indicated for brain | | | | imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR). | imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR). | | | Intended Users | Qualified Radiologist | Qualified Radiologist | Identical | | Type of Imaging Scans | MRI | MRI | Identical | | Target Organ/System | MR Brain | MR Brain | Identical | | Loading Multiple Studies | Yes | Yes | Identical | | Technological Features | Supports 1.5T Images Supports 3.0T Images Filtered Phase Maps Intensity Projection Automatic High-Pass Filtering B1 Correction N/A | Supports 1.5T Images Supports 3.0T Images Filtered Phase Maps Intensity Projection Automatic High-Pass Filtering B1 Correction CROWN | Identical | | Output Map | Enhanced T1 weighted images | T1 weighted images | Similar | | | | T1 weighted images with white noise reduced via CROWN | | | | SWI | SWI | Similar | | | | SWI with white noise reduced via CROWN | | | | SWIM | SWIM | Identical | | | pSWIM | pSWIM | Identical | | | mpSWIM | mpSWIM | Identical | | | tSWI (SWI algorithm) | tSWI | Similar | | | | tSWI with white noise reduced via CROWN | | | | MRA (intensity projection) | MRA | Identical | | | |…