(59 days)
No
The document describes standard MR imaging processing methods and workflow features, with no mention of AI or ML.
No.
The device is described as a "magnetic resonance diagnostic device" used for producing images to "assist the diagnosis," not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "magnetic resonance diagnostic device (MRDD)" and that its images "may assist the diagnosis."
No
The device description explicitly lists numerous hardware components (magnet, RF power amplifier, coils, etc.) that are integral to its function as a magnetic resonance diagnostic device. The modifications described are additions and changes to software features and processing methods, but they are applied to an existing hardware system.
Based on the provided text, the uMR 570 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images of internal anatomical structure and/or function. This is a description of an in vivo imaging device, not a device that tests samples outside the body.
- Device Description: The description details components like magnets, RF coils, gradient coils, etc., which are characteristic of an MRI scanner used for imaging the human body directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining features of an IVD.
Therefore, the uMR 570 is an in vivo diagnostic imaging device, not an IVD.
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 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.
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.
The modification performed on the uMR 570 (K201540) in this submission is due to the following changes that include:
- (1) Addition and modification of pulse sequences
- a) New sequences: fse_dwi, grase, asl_3d, fse_mars_sle, gre_fine, gre_fg, gre bssfp ucs. svs wfs. svs stme.
- b) Added associated options for certain sequences: se_me (Add Inline T2 mapping), fse (Add OScan, Silicon-Only Image), fse arms (Add QScan), fse_mx (Add QScan), fse_ssh (Add QScan, Silicon-Only Image), fse_wfi (Add QScan), se (Add QScan), epi_dwi (Add QScan, MultiBand), epi_bold (Add QScan, MultiBand), epi_dti (Add QScan, MultiBand), gre_swi (Add QScan), gre_fsp (Add QScan), gre_quick (Add QScan), gre (Add QScan), gre_fsp_c (Add Cardiac T2* mapping), gre_bssfp (Add Cardiac T1 mapping, Cardiac T2 mapping).
- c) Added additional accessory equipment required for certain sequences: gre_tof (Add respiratory, cardiac gating).
- (2) Addition of MR imaging processing methods: Inline T2 mapping, Cardiac T1 mapping, Cardiac T2 mapping, Cardiac T2* mapping, Flow Quantification, Arterial Spin Labeling (3D ASL).
- (3) Addition of Spectroscopy Sequences and Post Processing Features: SVS MRS (Liver), Prostate MRS, SVS MRS (Breast).
- (4) Addition of New function: Implant mode, Remote Assistance.
- (5) Addition of New Workflow Features: EasyScan.
These modifications do not affect the intended use or alter the fundamental scientific technology of the device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
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 performed as described in the guidance/standards:
-
A MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Non-clinical testing were conducted to verify the features described in this premarket submission. -
A Clinical performance evaluation
-
Performance evaluation report for Flow Quantification,3D ASL, Inline T2 A Mapping, Flow Quantification, Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping, MARS+, MultiBand, QScan, Silicon-Only Imaging.
-
A Performance testing for Spectroscopy: Prostate MRS, SVS MRS (Breast), SVS MRS (Liver).
-
System Validation report: Implant mode, Remote Assistance, EasyScan.
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)
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.
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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.
May 18, 2023
Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K230758
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: March 20, 2023 Received: March 20, 2023
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
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,
D.G.K.
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
2
Indications for Use
510(k) Number (if known) K230758
Device Name uMR 570
Indications for Use (Describe)
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 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.
| 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 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 text is a stylized "U" shape, which is dark blue with a white line running vertically through the center. The logo is simple and modern, and the use of blue and white gives it a clean and professional look.
510 (k) SUMMARY
1. Date of Prepared
March 20, 2023
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: 21 CFR 892.1000 Device Class: II
4. Identification of Predicate Devices(s)
Predicate Device 510(k) Number: K201540 Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
Reference Device 510(k) Number: K222755 Device Name: uMR 680 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
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Image /page/4/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 dark teal in color. The logo is simple and modern.
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 standards.
The modification performed on the uMR 570 (K201540) in this submission is due to the following changes that include:
- (1) Addition and modification of pulse sequences
- a) New sequences: fse_dwi, grase, asl_3d, fse_mars_sle, gre_fine, gre_fg, gre bssfp ucs. svs wfs. svs stme.
- b) Added associated options for certain sequences: se_me (Add Inline T2 mapping), fse (Add OScan, Silicon-Only Image), fse arms (Add QScan), fse_mx (Add QScan), fse_ssh (Add QScan, Silicon-Only Image), fse_wfi (Add QScan), se (Add QScan), epi_dwi (Add QScan, MultiBand), epi_bold (Add QScan, MultiBand), epi_dti (Add QScan, MultiBand), gre_swi (Add QScan), gre_fsp (Add QScan), gre_quick (Add QScan), gre (Add QScan), gre_fsp_c (Add Cardiac T2* mapping), gre_bssfp (Add Cardiac T1 mapping, Cardiac T2 mapping).
- c) Added additional accessory equipment required for certain sequences: gre_tof (Add respiratory, cardiac gating).
- (2) Addition of MR imaging processing methods: Inline T2 mapping, Cardiac T1 mapping, Cardiac T2 mapping, Cardiac T2* mapping, Flow Quantification, Arterial Spin Labeling (3D ASL).
- (3) Addition of Spectroscopy Sequences and Post Processing Features: SVS MRS (Liver), Prostate MRS, SVS MRS (Breast).
- (4) Addition of New function: Implant mode, Remote Assistance.
- (5) Addition of New Workflow Features: EasyScan.
These modifications do not affect the intended use or alter the fundamental scientific technology of the device.
6. Intended Use
The uMR 570 system system are 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
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Image /page/5/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" shape, which also resembles a shield with a vertical line through the center. The color of the logo is a dark teal or gray.
The differences from the predicate device are discussed in the comparison table in this submission as below.
| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K201540) | Remark |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| 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 (K201540) | 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 |
| Temporomandibula
r Joint Coil - 4 | Yes | Yes | Same |
| Head Coil - 24 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Patient table | | | |
| Dimensions | width 640mm,
height 880mm,
length 2620mm | width 640mm,
height 880mm,
length 2620mm | Same |
| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K201540) | Remark |
| 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 |
| 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 |
| Surface Heating | NEMA MS 14 | ES 60601-1 | Note 1 |
Table 1 Comparison of Hardware configuration
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Image /page/6/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is dark gray in color. The logo is simple and modern in design.
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is divided vertically into two halves. The logo is simple and modern, with a focus on the company's name and a clean, geometric design.
| Note 1 | The NEMA standards publication MS 14-2019 describes the procedure for heating RF coil heating under worst-case normal operating conditions. The results for the surface heating test showed that proposed devices perform as well as predicate devices. |
|---|---|
| -------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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 (K201540) | Remark |
|---------------------------------------|----------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Processing Features | | | |
| Inline T2
Mapping | Yes | No | Inline T2 Map is substantially
equivalent to T2 Map processed
by post-processing module. The
map result displays inline without
extra operation by post-
processing module. |
| Arterial Spin
Labeling (3D
ASL) | Yes | No | 3D ASL is substantially
equivalent to FSE and uses extra
arterial spin labeling preparation
and imaging processing for
cerebral blood flow (CBF)
imaging without contrast agent. |
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Image /page/8/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is also in bold. The logo is simple and modern, and the colors are muted.
| Flow
Quantification
(FQ) | Yes | No | FQ is substantially equivalent to
GRE and uses extra flow
encoding and imaging processing
for flow quantification. |
|--------------------------------|-----|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardiac T1
Mapping | Yes | No | Cardiac T1 mapping is
substantially equivalent to GRE
and uses multiple TI acquisitions
with IR preparation and imaging
processing for cardiac T1
mapping. |
| Cardiac T2
Mapping | Yes | No | Cardiac T2 mapping is
substantially equivalent to GRE
and uses multiple T2-prep
duration preparation acquisitions
and imaging processing for
cardiac T2 mapping. |
| Cardiac T2*
Mapping | Yes | No | Cardiac T2* mapping is
substantially equivalent to GRE
and uses multiple TE acquisitions
and imaging processing for
cardiac T2* mapping. |
| Spectroscopy Features | | | |
| SVS MRS
(Liver) | Yes | No | Liver spectroscopy is
substantially equivalent to
Spectroscopy and uses multi-echo
acquisition and post-processing
instead of single echo for fat
quantification of liver. |
| Prostate MRS | Yes | No | Prostate spectroscopy is
substantially equivalent to
Spectroscopy and uses
characteristic metabolites
detection post processing for
prostate spectroscopy. |
| SVS MRS
(Breast) | Yes | No | Breast spectroscopy is
substantially equivalent to
Spectroscopy and uses
characteristic metabolites
detection post processing for
breast spectroscopy. |
Table 3 provides the new function and workflow features of the reference device in comparison to the predicate device.
Table 3 Comparison of the new function and workflow features
| ITEM | This Submission | Reference Device uMR 680
(K222755) | Remark |
|----------|-----------------|---------------------------------------|--------|
| Function | | | |
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Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is also in bold. The logo is simple and modern.
| Implant Mode | Yes | Yes | Same |
|---|---|---|---|
| Remote Assistance | Yes | Yes | Same |
| Workflow Features | |||
| EasyScan | Yes | Yes | Same |
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness in hardware and software as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.
8. Performance Data
The following testing was performed as described in the guidance/standards:
-
A MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Non-clinical testing were conducted to verify the features described in this premarket submission. -
A Clinical performance evaluation
-
Performance evaluation report for Flow Quantification,3D ASL, Inline T2 A Mapping, Flow Quantification, Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping, MARS+, MultiBand, QScan, Silicon-Only Imaging.
-
A Performance testing for Spectroscopy: Prostate MRS, SVS MRS (Breast), SVS MRS (Liver).
-
System Validation report: Implant mode, Remote Assistance, EasyScan.
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 conclude 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.