(105 days)
Not Found
No
The document describes standard MRI technology and image processing techniques, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is described as a "magnetic resonance diagnostic device" used to produce images "that may assist the diagnosis," indicating a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a magnetic resonance diagnostic device (MRDD)" and that the images it produces, "when interpreted by a trained physician yield information that may assist the diagnosis."
No
The device description explicitly lists numerous hardware components, including a magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images of internal anatomical structures and/or function. It is used to assist in diagnosis based on these images and derived parameters, interpreted by a trained physician. This is the definition of an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
- Device Description: The description details the components of an MRI system, which is used to image the inside of a living body. IVD devices typically involve testing samples (like blood, urine, tissue) outside of the body.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in-vivo imaging technique.
- Anatomical Site: The device is used to image the head, body, and extremities, which are parts of a living organism.
- Performance Studies: The performance studies listed are related to the technical performance of an MRI system (image quality, safety standards for medical electrical equipment, etc.) and clinical performance evaluation, not the performance of a test on biological samples.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.
N/A
Intended Use / Indications for Use
The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the imerpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
Product codes
LNH
Device Description
The uMR 570 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet. RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 570 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
head, body and extremities
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted on the proposed devices:
- A Image Signal to Noise Ratio
- A Image Uniformity
- A Performance testing for Spectroscopy, Computed DWI
- A Surface Heating of RF Receive
- A ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance
-
IEC 60601-2-33 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- Clinical performance evaluation A
- A Biocompatibility
- A Performance testing for Inline T1/T2*Map
- A Performance testing for SWI+
-
Performance testing for Easy-scan
The test results demonstrated that the device performs as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K200024
Trade/Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: April 3, 2020 Received: April 7, 2020
Dear Xin Gao:
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
April 20, 2020
1
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 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.
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
Indications for Use
510(k) Number (if known)
Device Name uMR 570
The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the imerpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
| 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) |
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Image /page/3/Picture/2 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized graphic element that resembles a shield or emblem. The emblem is divided vertically by a white line, and a horizontal white line crosses the vertical line near the top, creating a "T" shape within the shield.
510 (k) SUMMARY
1. Date of Prepared
April 03, 2020
2. Sponsor Identification
Shanghai United Imaging Healthcare Co., Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device(s)
Trade Name: uMR 570 Common Name: Magnetic Resonance Diagnostic Device Model: uMR 570 Product Code: LNH Regulation Number: 892.1000 Device Class: II
4. Identification of Predicate Devices(s)
Predicate Device 510(k) Number: K180925 Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
5. Device Description
The uMR 570 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet. RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 570 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark blue. The logo is simple and modern in design.
standards.
uMR 570 has been previously cleared by FDA via K180925.
The modification performed on the uMR 570(K180925) in this submission is due to the following changes that include:
- Addition of Radio Frequency Coils: Head Coil-24, Head Coil-12, Carotid Coil-8 1.
- Addition and modification of pulse sequences 2.
- New sequences: gre quick wfi, hise, gre quick 4dcemra, gre ute, a) gre_maps
- b) Broadened application scope of Contrast characteristic for certain sequences: T1,T2, Pd, T2/T1
- Added certain sequences Associated options: dark blood, navigator, multic) echo , reduced-FOV, cDWI
- Added Reconstruction method for certain sequences: compressed sensing d)
-
- Addition of imaging processing methods: FACT(Fat Analysis and Calculation Technique), PSIR (Phase Sensitive Inversion Recovery), cDWI (Computed DWI), Inline T1/T2* Map, SWI+ (Susceptibility Weighted Imaging Plus)
These modifications do not affect the intended use or alter the fundamental scientific technology of the device.
6. Intended Use
The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
7. Technological Characteristic
The differences from the predicate device are discussed in the comparison table in this submission is added below.
| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K180925) | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K180925) | Remark |
| Indications For Use | The uMR 570 system is
indicated for use as a
magnetic resonance
diagnostic device
(MRDD) that produces
sagittal, transverse,
coronal, and oblique
cross sectional images,
and spectroscopic
images, and that display
internal anatomical
structure and/or function
of the head, body and
extremities.
These images and the
physical parameters
derived from the images
when interpreted by a
trained physician yield
information that may
assist the diagnosis.
Contrast agents may be
used depending on the
region of interest of the
scan. | The uMR 570 system is
indicated for use as a
magnetic resonance
diagnostic device
(MRDD) that produces
sagittal, transverse,
coronal, and oblique
cross sectional images,
and spectroscopic
images, and that display
internal anatomical
structure and/or function
of the head, body and
extremities.
These images and the
physical parameters
derived from the
images when
interpreted by a trained
physician yield
information that may
assist the diagnosis.
Contrast agents may be
used depending on the
region of interest of the
scan. | Same |
| Magnet system | | | |
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessible bore
dimensions | width 700mm,
height 530mm,
length 1500mm | width 700mm,
height 530mm,
length 1500mm | Same |
| Type of
Shielding | Actively shielded, OIS
technology | Actively shielded, OIS
technology | Same |
| Magnet
Homogeneity | 1.4ppm @ 50cm DSV
0.9ppm @ 45cm DSV
0.72ppm @ 40cm DSV
0.420ppm @ 30cm DSV
0.240ppm @ 20cm DSV
0.040ppm @ 10cm DSV | 1.4ppm @ 50cm DSV
0.9ppm @ 45cm DSV
0.72ppm @ 40cm DSV
0.420ppm @ 30cm DSV
0.240ppm @ 20cm DSV
0.040ppm @ 10cm DSV | Same |
| ITEM | Proposed Device uMR 570 | Predicate Device uMR 570 (K180925) | Remark |
| Max gradient amplitude | 45mT/m | 45mT/m | Same |
| Max slew rate | 200T/m/s | 200T/m/s | Same |
| Shielding | active | active | Same |
| Cooling | water | water | Same |
| RF system | | | |
| Resonant frequencies | 63.87 MHz | 63.87 MHz | Same |
| Number of transmit channels | 1 | 1 | Same |
| Number of receive channels | Up to 48 | Up to 48 | Same |
| Amplifier peak power per channel | 20 kW | 20 kW | Same |
| RF Coils | | | |
| Head & Neck Coil -16 | Yes | Yes | Same |
| Body Array Coil - 6 | Yes | Yes | Same |
| Body Array Coil - 12 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Flex Coil Large - 4 | Yes | Yes | Same |
| Flex Coil Small - 4 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower Extremity Coil - 24 | Yes | Yes | Same |
| Shoulder Coil - 12 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Spine Coil - 24 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Cardiac Coil - 24 | Yes | Yes | Same |
| Foot & Ankle Coil - 24 | Yes | Yes | Same |
| Temporomandibular Joint Coil - 4 | Yes | Yes | Same |
| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K180925) | Remark |
| Head Coil - 24 | Yes | No | The intended use is
equivalent to
previously cleared
Head & Neck Coil -16
for head scan. More
coil elements in the
new coil allow better
image quality and
acceleration. |
| Head Coil - 12 | Yes | No | The intended use is
equivalent to
previously cleared
Head & Neck Coil -16
for head scan. More
coil elements in the
new coil allow better
image quality and
acceleration. |
| Carotid Coil - 8 | Yes | No | The intended use is
equivalent to
previously cleared
Flex Coil Small - 4 for
neck scan. More coil
elements in the new
coil allow better image
quality and
acceleration. |
| Patient table | | | |
| Dimensions | width 640mm, height
880mm, length 2620mm | width 640mm, height
880mm, length
2620mm | Same |
| Maximum
supported
patient weight | 250 kg | 250 kg | Same |
| Accessories | | | |
| Vital Signal
Gating | ECG, Peripheral Pulse
Gating, Respiratory Gating | ECG, Peripheral Pulse
Gating, Respiratory Gating | Same |
| Safety | | | |
| Electrical Safety | Comply with ES60601-1 | Comply with ES60601-
1 | Same |
| EMC | Comply with IEC60601-
1-2 | Comply with
IEC60601-1-2 | Same |
| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K180925) | Remark |
| Max SAR for
Transmit Coil | Comply with IEC
60601-2-33 | Comply with IEC
60601-2-33 | Same |
| Max dB/dt | Comply with IEC
60601-2-33 | Comply with IEC
60601-2-33 | Same |
| Biocompatibility | Patient Contact Materials
were tested and
demonstrated no
cytotoxicity (ISO 10993-
5), no evidence for
irritation and
sensitization (ISO
10993-10). | Patient Contact
Materials were tested
and demonstrated no
cytotoxicity (ISO
10993-5), no evidence
for irritation and
sensitization (ISO
10993-10). | Same |
Table 1 Comparison of Hardware configuration
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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a dark color. The logo appears to be for a company in the imaging or medical technology field.
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Image /page/6/Picture/1 description: The image contains the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized logo that appears to be a letter "U" with a vertical line running through the center, creating a negative space "I" shape. The color of the text and logo is a dark teal or gray.
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark gray. The logo is simple and modern.
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized letter "U" that is also in a bold font. The logo is a dark teal color.
Table 2 provides the new application software features of the proposed device in comparison to the predicate device.
Table 2 Comparison of the new Application Software Features
| ITEM | Proposed
Device
uMR 570 | Predicate
Device
uMR 570
(K180925) | Remark |
|-------------------------------------------------|-------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Imaging Features | | | |
| Inline T1/T2Map | Yes | No | Inline T1/T2Map is significantly
equivalent to single-echo/multi-
echo gradient-
echo imaging. Quantitative T1 an
d T2* maps are generated from va
riable flip angle and multi-
echo images, respectively. |
| Phase Sensitive
Inversion Recovery
(PSIR) | Yes | No | PSIR is substantially equivalent
to conventional inversion recover
y (IR) and uses phase sensitive rec
onstruction to produce real image
instead of magnitude image. |
| Computed DWI (cDWI) | Yes | No | cDWI calculates and outputs
diffusion-weighted images with
user-input b-values and is
substantially equivalent to
conventional DWI. |
| Susceptibility Weighted
Imaging Plus (SWI+) | Yes | No | SWI+ is substantially equivalent
to SWI and uses multi-echo in
acquisition and reconstruction
instead of single echo. |
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Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized letter "U" that is split in the middle by a vertical line. The logo is simple and modern, and the colors are muted.
| Easy Scan | Yes | No | Easy Scan feature allows
automatic slice positioning for
head, cardiac, c-spine and knee
imaging. The positioning can also
be adjusted manually from user.
The final positioning effect is
equivalent to manual operation
without Easy Scan feature. |
| ----------- | ----- | ---- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8. Substantial Equivalence
The following testing was conducted on the proposed devices:
- A Image Signal to Noise Ratio
- A Image Uniformity
- A Performance testing for Spectroscopy, Computed DWI
- A Surface Heating of RF Receive
- A ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance
-
IEC 60601-2-33 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- Clinical performance evaluation A
- A Biocompatibility
- A Performance testing for Inline T1/T2*Map
- A Performance testing for SWI+
-
Performance testing for Easy-scan
The test results demonstrated that the device performs as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared.
9. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we concludes that uMR 570 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.