(124 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard MR hardware components and sequences.
No
This device is a diagnostic imaging system (Magnetic Resonance Diagnostic Device) used to assist in diagnosis, not to provide therapy.
Yes
The "Device Description" explicitly states, "The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device..."
No
The device description explicitly lists numerous hardware components (magnet, RF power amplifier, RF coils, etc.), indicating it is a physical medical device, not software-only.
Based on the provided information, the uMR Omega system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device produces images of internal anatomical structure and/or function of the head, body, and extremities. These images are then interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic imaging device, not an in vitro diagnostic device.
- Device Description: The description details a magnetic resonance diagnostic device that interacts directly with the patient (patient bore, patient table, RF coils, etc.). IVD devices typically analyze samples taken from the body (blood, urine, tissue, etc.) outside of the body.
- Input Imaging Modality: The input is Magnetic Resonance (MR), which is an in vivo imaging technique.
- Anatomical Site: The device is used on the head, body, and extremities, indicating direct interaction with the patient.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic purposes. The uMR Omega system operates by imaging the inside of the living body.
N/A
Intended Use / Indications for Use
The uMR Omega system is indicated for use as a magnetic 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 Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm 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 Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR Omega has been previously cleared by FDA via K220332.
The modification performed on the uMR Omega (K220332) in this submission is due to the following changes that include:
- (1) Addition of the Radio Frequency Power Amplifier model: uXD2201.
- (2) Addition of Radio Frequency Coils: Tx/Rx Knee Coil -24 and SuperFlex Body Wide - 24.
- (3) Addition of VSM models: uVWMERP, uMVRX and mmw100.
- (4) Addition and modification of pulse sequences
- New sequences: gre_snap, gre_quick_4dncemra, gre_trass, epi_se_mre, gre_fq. a)
- b) Added Associated options for certain sequences: T1Rho, CEST, FSP+ (eT1, eGM), silica gel imaging, mPLD, whole heart coronary angiography imaging.
- Name change of pulse sequence: gre (old name: gre sp), gre fine (old name: c) gre_bssfp_fi), gre_quick (gre_quick_wfi merge to gre_quick), gre_quick (gre_bloustracking merge to gre_quick).
- (5) Addition of imaging processing methods: 4D Flow Quantification, Magnetic Resonance Elastography (MRE), SNAP, CEST, T1Rho, FSP+.
- (6) Addition of Dockable Patient Table.
- (7) Add the positioning workflow (uVision) with camera.
- (8) Addition of Resoundant Acoustic Driver System for Magnetic Resonance Elastography (MRE).
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 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
Non-clinical testing were conducted to verify the features described in this premarket submission.
- A Clinical performance evaluation
- A Performance evaluation report: 4D Flow (sequence: gre_fq); Magnetic Resonance Elastography (sequence: epi se mre); CEST (sequence: fse mx); T1rho (sequence: gre, fse mx); mPLD ASL (sequence: asl 3d); silica gel imaging (sequence: fse, fse arms, fse ssh).
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
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.
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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.
May 23, 2023
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist No.2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 China
Re: K230152
Trade/Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 24, 2023 Received: April 24, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230152
Device Name uMR Omega
Indications for Use (Describe)
The uMR Omega system is indicated for use as a magnetic 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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510 (k) SUMMARY
1. Date of Prepared
April 24, 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 Omega Common Name: Magnetic Resonance Diagnostic Device Model: uMR Omega Product Code: LNH Regulation Number: 21 CFR 892.1000 Device Class: II
4. Identification of Predicate Devices(s)
Predicate Device 510(k) Number: K220332 Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
5. Device Description
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm 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 Omega 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" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, also in a dark color, with a vertical line running down the center, creating a unique design element.
standards.
uMR Omega has been previously cleared by FDA via K220332.
The modification performed on the uMR Omega (K220332) in this submission is due to the following changes that include:
- (1) Addition of the Radio Frequency Power Amplifier model: uXD2201.
- (2) Addition of Radio Frequency Coils: Tx/Rx Knee Coil -24 and SuperFlex Body Wide - 24.
- (3) Addition of VSM models: uVWMERP, uMVRX and mmw100.
- (4) Addition and modification of pulse sequences
- New sequences: gre_snap, gre_quick_4dncemra, gre_trass, epi_se_mre, gre_fq. a)
- b) Added Associated options for certain sequences: T1Rho, CEST, FSP+ (eT1, eGM), silica gel imaging, mPLD, whole heart coronary angiography imaging.
- Name change of pulse sequence: gre (old name: gre sp), gre fine (old name: c) gre_bssfp_fi), gre_quick (gre_quick_wfi merge to gre_quick), gre_quick (gre_bloustracking merge to gre_quick).
- (5) Addition of imaging processing methods: 4D Flow Quantification, Magnetic Resonance Elastography (MRE), SNAP, CEST, T1Rho, FSP+.
- (6) Addition of Dockable Patient Table.
- (7) Add the positioning workflow (uVision) with camera.
- (8) Addition of Resoundant Acoustic Driver System for Magnetic Resonance Elastography (MRE).
These modifications do not affect the intended use or alter the fundamental scientific technology of the device.
6. Intended Use
The uMR Omega 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 as below.
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR Omega (K220332) | Remark |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| 510(K) No. | | K220332 | |
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR Omega (K220332) | Remark |
| 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 Omega 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 Omega 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 | 3.0 Tesla | 3.0 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessible
bore dimensions | 75cm | 75cm | Same |
| Type of Shielding | Actively shielded, OIS
technology | Actively shielded, OIS
technology | Same |
| Magnet
Homogeneity | 2.30ppm @ 50cm DSV
0.80ppm @ 45cm DSV
0.38ppm @ 40cm DSV
0.08ppm @ 30cm DSV
0.02ppm @ 20cm DSV
0.002ppm @ 10cm DSV | 2.30ppm @ 50cm DSV
0.80ppm @ 45cm DSV
0.38ppm @ 40cm DSV
0.08ppm @ 30cm DSV
0.02ppm @ 20cm DSV
0.002ppm @ 10cm DSV | Same |
| Gradient system | | | |
| 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 | | | |
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR Omega (K220332) | Remark |
| Resonant
frequencies | 128.23 MHz | 128.23 MHz | Same |
| Number of transmit
channels | 2 | 2 | Same |
| Number of receive
channels | Up to 96 | Up to 96 | Same |
| Amplifier peak
power per channel | 18 kW, 20 kW | 18 kW | Note 1 |
| RF Coils | | | |
| Volume Transmit
Coil | Yes | Yes | Same |
| Head & Neck Coil -
24 | Yes | Yes | Same |
| Body Array Coil -
12 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Flex Coil Large - 8 | Yes | Yes | Same |
| Flex Coil Small - 8 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower Extremity
Coil - 36 | Yes | Yes | Same |
| Shoulder Coil - 12 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Spine Coil - 32 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Cardiac Coil - 24 | Yes | Yes | Same |
| Temporomandibular
Joint Coil - 4 | Yes | Yes | Same |
| Foot & Ankle Coil -
24 | Yes | Yes | Same |
| Head Coil - 32 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Infant Coil - 24 | Yes | Yes | Same |
| Body Array Coil -
24 | Yes | Yes | Same |
| Head & Neck Coil -
48 | Yes | Yes | Same |
| Spine Coil - 48 | Yes | Yes | Same |
| Head Coil - 64 | Yes | Yes | Same |
| SuperFlex Body -
24 | Yes | Yes | Same |
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR Omega (K220332) | Remark |
| SuperFlex Large -
12 | Yes | Yes | Same |
| SuperFlex Small -
12 | Yes | Yes | Same |
| Tx/Rx Knee Coil -
24 | Yes | No | Note 2 |
| SuperFlex Body
Wide - 24 | Yes | No | Note 3 |
| Dimensions | Patient Table:
width 640mm, height 880mm,
length 2620mm
Dockable Patient Table:
width 826mm, height 880mm,
length 2578mm | width 640mm, height 880mm,
length 2620mm | Note 4 |
| Maximum
supported patient
weight | Patient Table:
310 kg
Dockable Patient Table:
310kg | 310 kg | Same |
| Vital Signal Gating | Wireless UIH Gating Unit
453564324621
ECG module
989803163121
SpO2 module
989803163111
(alternative) | Wireless UIH Gating Unit
453564324621
ECG module
989803163121
SpO2 module
989803163111
(alternative) | Same |
| | ECG, Rrespiration and pulse
module
uVWMERP
Wireless gating trigger unit
uMVRX
(alternative) | / | Note 5 |
| | Respiration module | / | Note 6 |
| | mmw100
(optional) | / | |
| Max View Angle | 75° | / | Note 7 |
| Positioning Error | $\leq \pm 5cm$ | / | Note 7 |
| Electrical Safety | Comply with ES 60601-1 | Comply with ES 60601-1 | Same |
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR Omega (K220332) | Remark |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | 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 | NEMA MS 14 | 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 in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is composed of a vertical line and a horizontal line, with a curved bottom.
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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 a bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted.
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING". To the right of the text is a stylized letter "U" that is dark blue. 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" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The symbol is a dark gray color, and the text is a slightly lighter shade of gray.
| Note 1 | This submission adds a new radio frequency power amplifier model (uXD2201), which increases the
amplifier peak power. The increase of peak output power is to reserve power margin for the magnetic
resonance imaging system to better adapt to the scanning of patients with large loads, which is beneficial
to the effectiveness of the system. |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | The intended use of Tx/Rx Knee Coil is essentially identical to previously cleared Knee Coil -12. The first
difference is that the Tx/Rx Knee Coil is of a 16 Legs High-Pass Birdcage used for transmitter coil. The
second difference is the number of channels of the receiver coil. |
| Note 3 | The intended use of Super Flex Wide - 24 is essentially identical to previously cleared Body Array Coil -
24. The differences are the material used on the surface of the coil. The flexible material is beneficial to
wrap the scanning parts. |
| Note 4 | This submission adds Dockable Patient Table to facilitate patient transfer. |
| Note 5 | Compared to the predicate device, the proposed device add an alternative VSM model (include
uVWMERP and uMVRX). The trigger method, principle, connection mode, installation position and other
aspects of this model are completely consistent with the original model. |
| Note 6 | Compared to the predicate device, the proposed device adds a respiratory gating mmw100 to monitor
patient respiration. Compared with contact respiratory gating, mmw100 eliminates the operation of patient
binding before scan, thus improving patient scan comfort. |
| Note 7 | This submission adds a new positioning method using uVision to automatically move the located position
to the isocenter of the magnet. This method reduces the steps of positioning and improves the previous
cumbersome operation mode. |
| | Table 2 provides the new application software features of the proposed device in |
software features of the proposed device comparison to the predicate device.
Table 2 Comparison of the new Application Software Features
| ITEM | Proposed
Device
uMR Omega | Predicate
Device
uMR Omega
(K220332) | Remark |
|---------------------------|---------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Processing Features | | | |
| 4D Flow Quantification | Yes | No | 4D Flow Quantification is substantially
equivalent to GRE and uses extra three
direction flow encoding gradients and
repeats several times acquisition, and
then uses specific imaging processing for |
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Image /page/9/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 sans-serif font. To the right of the text is a stylized "U" shape, which is made up of two vertical bars and a horizontal bar in the middle. The logo is simple and modern, and the use of a sans-serif font gives it a clean and professional look.
| | | | 4D (3D space directions and 1D time
direction) flow quantification. |
|------------------------------------------|-----|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Magnetic Resonance
Elastography (MRE) | Yes | No | Magnetic Resonance Elastography
(MRE) is substantially equivalent to
EPI_SE and uses extra motion encoding
gradient to capture micro shear wave
motion induced by vibration device and
specific imaging processing for stiffness
quantification. |
| SNAP | Yes | No | SNAP is substantially equivalent to GRE
with two TI acquisitions and uses
specific imaging processing to attain
Simultaneous Non-contrast Angiography
and intraPlaque hemorrhage images. |
| CEST | Yes | No | CEST is substantially equivalent to
FSE_MX and uses extra chemical
exchange saturation preparation pulse
with different resonance frequencies to
attain Z-spectrum and final CEST image. |
| T1Rho | Yes | No | T1Rho is substantially equivalent to GRE
or FSE_MX and uses extra spin lock
preparation pulse to attain T1Rho
quantification mapping. |
| FSP+ | Yes | No | FSP+ is substantially equivalent to FSP
and acquires one more TI images.
According to two TI images, eT1 (T1
Enhanced) and eGM (Gray Matter
Enhanced) images can be attained by
specific image processing |
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 performance data according to FDA guidances and Recognized Consensus Standards were provided in support of the substantial equivalence determination.
- ES 60601-1 Medical electrical equipment Part 1: General requirements for basic A safety and essential performance
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Image /page/10/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 symbol that resembles a shield or a stylized letter U. The symbol is divided vertically by a white line, creating a distinct visual element.
- A IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance
- A IEC 60601-2-33 Ed. 3.1:2013. Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2020), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- A MS 9-2008(R2020), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- 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
- A Performance evaluation report: 4D Flow (sequence: gre_fq); Magnetic
Resonance Elastography (sequence: epi se mre); CEST (sequence: fse mx);
T1rho (sequence: gre, fse mx); mPLD ASL (sequence: asl 3d); silica gel
imaging (sequence: fse, fse arms, fse ssh).
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 Omega 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.