(119 days)
No
The document describes modifications to an existing MRI device, focusing on hardware changes, a new DWI technique, and a new user interface. There is no mention of AI, ML, or any related image processing or analysis techniques that would typically indicate the use of such technology.
No
Explanation: The device is described as a "diagnostic total body imaging device" that produces images useful "in the determination of a diagnosis," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "MRopen 0.5 T is a diagnostic total body imaging device." Additionally, it mentions that the images produced "can yield information that can be useful in the determination of a diagnosis" when interpreted by a trained physician.
No
The device description explicitly states that the device is a total body magnetic resonance imaging device and details significant hardware components and modifications, including a magnet, spectrometer, compressors, cold heads, RFA, coils, and patient support. While it mentions software updates (User Interface and DWI technique), it is clearly not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The MRopen 0.5 T is a Magnetic Resonance Imaging (MRI) device. It produces images of the internal structure of the body directly by interacting with the patient's body using magnetic fields and radio waves. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic total body imaging device" that produces "cross-sectional images that display the internal structure of the body." This aligns with the function of an imaging device, not an IVD.
Therefore, the MRopen 0.5 T is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
MRopen 0.5 T product is a Magnetic Resonance Diagnostic Device
MRopen 0.5 T is Total Body MRDD with the following limitation: no cardiac imaging, no breast imaging.
MRopen 0.5 T Tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the anatomies. The examinations may be performed both in weight free (supine) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
The new MRopen 0.5 T Tomograph can perform DWI images based on a Diffusion excitation pattern applied on a specific acquisition sequence, in this case the HASTE readout sequence. DWI is a well known diagnostic technique which does not rise safety and effectiveness issues different form the previously addressed ones when used as labeled.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
Like the previously cleared device K151466, the actual MRopen 0.5 T is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.
Modification of K15166 cleared device.
- Introduce DWI technique based on HASTE readout sequence
- Introduce internally developed User Interface
- Introduce changes in hardware such as spectrometer, compressors and cold heads, RFA
- Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils)
- Long Spine receiving coil
- Shoulder coil new model
- Changes to patient support shapes and courtesy cushions
MRopen 0.5 T is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The modification reflected in this Traditional 510(k) for the MRopen 0.5 T Tomograph are to introduce updates in hardware and software including the DWI technique previously not released. The modifications have not altered the scientific technology of the unmodified version MrOpen K151466 as detailed in below table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Total body (with limitations: no cardiac imaging, no breast imaging). Specific coils for C-Spine, Shoulder, Hand, MP-Loop, Flex S, Flex L, MP_Flat, Body, Knee, Head, Head/Neck, Spine, Long Spine.
Indicated Patient Age Range
Adult (healthy volunteers aged between 20 and 60)
Intended User / Care Setting
Trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A test was performed on healthy volunteers who agreed to cooperate to demonstrate performance of the device on humans. The healthy volunteers were adult male and female aged between 20 and 60 available in our firm. Only main changes were tested.
New DWI technique base on HASTE readout sequence: The images on healthy volunteers conform to the expected image quality. Both ADC calculated image and DWI images along the three main directions are displayed.
New Long Spine coil: The use of this new receiving coil has been referred to the previous spine model for equivalent or better quality image, with the workflow improvement of not new coil positioning in case of multiple scan of different streches of spine. Performance test report in Section 18.
Shoulder coil New model: This design is exactly the same employed in MrJ 3300 secondary predicate device which better fits the new patient comfort accessories during shoulder exam. Performance test report in Section 18.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical (bench) and clinical (healthy volunteers)
Sample Size: Healthy volunteers (adult male and female aged between 20 and 60 available in the firm). Specific sample size not provided.
Key Results: The non clinical (bench) and clinical (healthy volunteers) data demonstrate MRopen 0.5T to be as safe, as effective and performs as well than the predicates. Mropen 0.5 T is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.
The DWI technique on healthy volunteers showed expected image quality, with ADC calculated image and DWI images displayed along three main directions.
The new Long Spine coil showed equivalent or better quality images compared to the previous spine model, with improved workflow.
The new Shoulder coil design, same as K122034, better fits new patient comfort accessories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K151466, K082331, K032428, K122034
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ASG Superconductors S.p.A. % Luisella De Benedetti Quality and Regulatory Affairs Corso Ferdinando Maria Perrone 73/R Genova, 16152 ITALY
Re: K190524
Trade/Device Name: MRopen 0.5 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: May 14, 2019 Received: May 31, 2019
Dear Luisella De Benedetti:
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 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
July 1, 2019
1
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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
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6. Statement of Indications for Use (form 3881)
An21/778
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3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use |
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K190524 |
|---|---|
| K190524 | |
| Device Name | MRopen 0.5 T |
Indications for Use (Describe)
MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
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7. 510(k) Summary (21 CFR 807.92)
Date: (month/day/year) 05/14/2019
807.92(a)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;
Submitter Information
| Name | ASG Superconductors S.p.A. |
|---|---|
| Address | Corso Perrone 73R - 16152 Genova, Italy |
| Telephone n. | +39 010 6489 358 |
| Contact Person | Luisella De Benedetti |
| ASG Superconductors S.p.A. | |
| Corso F.M. Perrone 73R | |
| 16152 Genova | |
| +39 010 6489 358 | |
| debenedetti.luisella@as-g.it |
807.92(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Name of the device | MRopen 0.5 T |
|---|---|
| Trade name | ASG Superconductors |
| Classification name | Total Body Magnetic Resonance Diagnostic |
| Device | |
| Classification and class of device | 21 CFR 892.1000, class II |
| Classification Number | 90LNH |
AM 23/778
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Image /page/5/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of curved lines in different colors, including blue, green, yellow, orange, and red. The text "ASG" is in large, blue letters, and the word "SUPERCONDUCTORS" is in smaller, blue letters below "ASG".
807.92(a)(3) An identification of the legally marketed device to which the submitter claims equivalence.
PRIMARY PREDICATE (for all items excluded the below specified) Paramed S.r.1 Mr Open K151466 SECONDARY PREDICATE (FOR DWI-HASTE APPLICATION) K082331 Siemens Magnetom C! SECONDARY PREDICATE (FOR Compressors) AVANTO K032428 Siemens SECONDARY PREDICATE (FOR Spectrometer and shoulder coil) K122034 Paramed S.r.l MrJ 3300
807.92(a)(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;
Like the previously cleared device K151466, the actual MRopen 0.5 T is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.
Modification of K151466 cleared device.
- Introduce DWI technique based on HASTE readout sequence 0
- Introduce internally developed User Interface 0
- Introduce changes in hardware such as spectrometer, compressors and cold heads, 0 RFA
- 0 Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils)
- Long Spine receiving coil o
- 0 Shoulder coil new model
- Changes to patient support shapes and courtesy cushions o
MRopen 0.5 T is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
6
Image /page/6/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of curved lines in blue, green, yellow, orange, and red. The text "ASG SUPERCONDUCTORS" is in blue.
The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
The modification reflected in this Traditional 510(k) for the MRopen 0.5 T Tomograph are to introduce updates in hardware and software including the DWI technique previously not released. The modifications have not altered the scientific technology of the unmodified version MrOpen K151466 as detailed in below table.
| Claimed
| Feature | Discussion |
|---|---|
| Introduce DWI | |
| technique | |
| based on | |
| HASTE | |
| readout | |
| sequence | This sequence has been introduced to complete the sequence package of |
| the MRopen 0.5 T tomograph, now that the updated hardware and | |
| software grant better image quality results. Here the referred predicate | |
| is Siemens Magnetom C! K082331 Bibliography is supplied regarding | |
| this well-known technique | |
| Introduce | |
| internally | |
| developed | |
| User Interface | After many years of development it is possible to release this user |
| interface which is completely internally designed and excludes legacy | |
| software or software developed prior to IEC62304. | |
| Introduce changes in hardware such as: | |
| spectrometer | This spectrometer already employed for smaller tomograph ASG |
| Superconductors S.p.A. K122034 grants more flexibility to the new | |
| software granting DWI technique performance | |
| Compressors | |
| and cold heads | We intend to adopt as an alternative (to Leybold ones) for servicing and |
| for newly designed device the Sumitomo F70H compressor models | |
| already in use with Siemens AVANTO K0322428 predicate. CH-210 | |
| Cold Head are indicated to be used together with F70H compressors. | |
| Both compressors and Cold Heads are declared conformant to IEC | |
| 60601-1 by Sumitomo | |
| RFA | We intend to adopt as an alternative (to Analogic Corp.) for servicing |
| and for newly designed devices the RFT RF9200 9KW model | |
| Introduce | |
| change in | |
| hardware | |
| inside the | |
| magnet | |
| (double current | |
| same magnetic | |
| field) | ASG superconductors decided to double the current inside the magnet |
| while keeping unchanged the magnetic field to reduce the number of | |
| superconductive coils inside the vacuum chambers and this results in a | |
| cost reduction due to less MgB2 wire. | |
| No change in material which is the same MgB2 manufactured within ASG Superconductors S.p.A. Columbus Wire Business Unit No change in supplier manufacturing process Completely owned proprietary magnet construction process | |
| Long Spine | |
| receiving coil | This receiving coil is equivalent to standard Spine coil in K151466 |
| designed to fit a longer column segment. It allows performing exams on | |
| adjacent sections of the spine without moving the coil under the patient |
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Image /page/7/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized symbol to the left, consisting of curved lines in blue, green, yellow, orange, and red. To the right of the symbol is the text "ASG" in large, bold, blue letters, with the word "SUPERCONDUCTORS" in smaller blue letters underneath.
| Shoulder coil | This new model is derived from MrJ 3300 predicate device K122034
and it will be employed together with the new patient comfort
accessories supplied |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient comfort
accessories | back, but just adjusting patient table position inside the magnet
isocenter. |
| | Some new cushion shapes and supports have been studied to improve
comfort during shoulder and head exams (no new materials and
technologies) |
807.92(a)(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a) (3) of this section, the 510 (k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled;
MRopen 0.5 T product is a Magnetic Resonance Diagnostic Device
MRopen 0.5 T is Total Body MRDD with the following limitation: no cardiac imaging, no breast imaging.
MRopen 0.5 T Tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the anatomies. The examinations may be performed both in weight free (supine) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
Intended population is for Patients less than 200 Kg
The new MRopen 0.5 T Tomograph can perform DWI images based on a Diffusion excitation pattern applied on a specific acquisition sequence, in this case the HASTE
AM26/778
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Image /page/8/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized symbol on the left, resembling a series of curved lines in different colors (blue, green, yellow, orange, and red). To the right of the symbol is the text "ASG" in a bold, blue font, with the word "SUPERCONDUCTORS" written in smaller blue letters underneath. The overall design is clean and modern.
readout sequence. DWI is a well known diagnostic technique which does not rise safety and effectiveness issues different form the previously addressed ones when used as labeled.
807.92(a)(6) If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device identified in paragraph (a) (3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in paragraph (a) (3) of this section
Technological Characteristics
The MRopen 0.5 T MRI system is substantially equivalent to
| General item | MRopen 0.5 T | Primary Predicate
K151466
MrOpen | Secondary Predicate
Siemens Magnetom
C! K082331 | |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|---------|
| Anatomical regions | Total body with
the following
limitation: no
cardiac
imaging, no
breast imaging. | Total body with the
following limitation:
no cardiac imaging,
no breast imaging. | Total Body | |
| Nucleus excited | Proton (hydrogen nucleus) | | | |
| Diagnostic uses | Magnetic Resonance Diagnostic Device | | | |
| SCOUT Multiplanar | Yes | Yes | | |
| Ortogonal (SE ο GFE) | | | | |
| Spin echo T1 (SET1) | Yes | Yes | | |
| Spin echo T2 (SET2) | Yes | Yes | | |
| Short TE spin echo
(ERASE) | Yes | Yes | | |
| Double echo (DE) | Yes | Yes | | |
| Inversion recovery (IR) | | | | |
| Short TAU inversion
recovery (STIR) | Yes | Yes | | |
| General item | MRopen 0.5 T | Primary Predicate
K151466
MrOpen | Secondary Predicate
Siemens Magnetom
C! K082331 | |
| Short time inversion
recovery gradient field
echo (GFE-STIR) | Yes | Yes | | |
| Gradient Field Echo
(GFE) | Yes | Yes | | |
| Gradient Field Echo 3D
(3D-GFE) | Yes | Yes | | |
| RF spoiled gradient
echo 3D (3D-SPGFE) | Yes | Yes | | |
| Time reversed 3D
gradient Field Echo
(3D-EMIT) | Yes | Yes | | |
| Rapid Imaging SE T2
(RISE) | Yes | Yes | | |
| Rapid Imaging DE
(RIDE) | Yes | Yes | | |
| Fast Inversion Recovery
(FIR) | Yes | Yes | | |
| FLAIR - Fluid
attenuated Inversion
Recovery | Yes | Yes | | |
| Spin Echo Presat -
FAST RISE9 PRESAT | Yes | Yes | | |
| Fast Rise (up to 16
echoes) | Yes | Yes | | |
| Fast PD (Fast proton
density) | Yes | Yes | | |
| 3D Gradient Balanced
Steady State (3D-
GBASS) | Yes | Yes | | |
| Fat-Water separation T1
(FWS T1) | Yes | Yes | | |
| ANGIO sequences | Yes | Yes | | |
| General item | MRopen 0.5 T | Primary Predicate | Secondary Predicate | |
| | | K151466
MrOpen | Siemens Magnetom
C! K082331 | |
| HASTE sequence | Yes | No | Yes | |
| DWI technique | Yes | No | Yes | |
| General item | MRopen 0.5 T | Primary | Predicate | K151466 |
| | | MrOpen | | |
| Magnetic system | • | High homogeneity Open-sky Magnet, based on high temperature
cryogenless superconductive, horizontal field | | |
| | Maximum Magnetic field 0.5 Tesla | | | |
| | Current 146A | Current 84 A | | |
| | 28000 kg | | | |
| | 200x200x170 cm (HxDxW) | | | |
| | 4.0 x 4.6 x 3.6 m (Vertical x Transversal x Longitudinal) | | | |
| |