(128 days)
Not Found
No
The 510(k) summary describes a standard MRI system and does not mention any AI or ML components or functionalities.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images that "may assist the diagnosis," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" states that the device is a "magnetic resonance diagnostic device (MRDD)" and that the images and derived physical parameters "may assist the diagnosis." The "Device Description" also refers to it as a "magnetic resonance diagnostic device."
No
The device description explicitly lists numerous hardware components (magnet, RF coils, gradient coils, patient table, etc.) and describes it as a 3.0T superconducting magnetic resonance diagnostic device, which is a hardware-based imaging system.
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 structure and/or function. It is used to assist in diagnosis based on the interpretation of these images by a trained physician.
- Device Description: The description details the components of an MRI system, which is an imaging modality used to visualize internal structures.
- Nature of IVDs: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
This device operates by generating magnetic fields and radio waves to create images of the inside of the body, which is an in vivo diagnostic method, not an in vitro one.
N/A
Intended Use / 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 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 the scan.
Product codes
LNH
Device Description
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a ultra-wide patient bore size design. 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.
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)
Non-Clinical Tests:
- ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- 60601-2-33 Ed. 3.2:2015 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in A Diagnostic Magnetic Resonance Images
- MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- MS 8-2016, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
Clinical Tests:
- A volunteer study was used to determine the safety limits associated with gradient-A induced nerve stimulation.
- Sample clinical images were provided to support the ability of uMR Omega to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
Key Results: The test results demonstrated that the device performs as expected and thus, it is substantially 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). 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.
Shanghai United Imaging Healthcare Co., Ltd. Jiading District % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA
Re: K193200
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: March 11, 2020 Received: March 12, 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
March 27, 2020
1
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,
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) K193200
Device Name uMR Omega
Indications for Use (Describe)
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 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 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/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 is dark gray. The logo is simple and modern.
510 (k) SUMMARY
1. Date of Prepared
March 11, 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 Omega Common Name: Magnetic Resonance Diagnostic Device Model(s): uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K191157 Device Name: uMR 780 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 ultra-wide patient bore size design. 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
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Image /page/4/Picture/1 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 "U" symbol, which is also in a bold font. The color of the text and the "U" symbol appears to be a dark gray or charcoal color.
Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
6. 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.
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 Omega | Predicate Device
uMR 780 (K191157) | 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 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 | The uMR 780
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 | Same |
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR 780 (K191157) | Remark |
| | from the images | from the images | |
| | when interpreted by
a trained physician | 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. | yield information
that may assist the
diagnosis. Contrast
agents may be used
depending on the
region of interest of
the scan. | |
| Magnet system | | | |
| Field Strength | 3.0 Tesla | 3.0 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-
accessible bore
dimensions | 75cm | 65cm | Larger bore size for patients
comfort during scanning
without compromising other
imaging functions. |
| Type of
Shielding | Actively shielded,
OIS technology | Actively shielded,
OIS technology | Same |
| Magnet
Homogeneity | 2.3ppm @ 50cm DSV
0.8ppm @ 45cm DSV
0.38ppm @ 40cm
DSV
0.08ppm @ 30cm
DSV
0.02ppm @ 20cm
DSV
0.002ppm @ 10cm
DSV | 2.4ppm @ 50cm DSV
0.8ppm @ 45cm DSV
0.39ppm @ 40cm
DSV
0.11ppm @ 30cm
DSV
0.038ppm @ 20cm
DSV
0.002ppm @ 10cm
DSV | In order to support larger bore
size, uMR Omega system has a
bigger magnet design.
Compared with the predicate
device, the size and 5-gauss
line range is larger. The
homogeneity of the magnet is
equal or better at typical DSVs
thus clinical scanning is not
limited compared to predicate
device. |
| Gradient system | | | |
| Max gradient
amplitude | 45mT/m | 42mT/m | The higher Maximum Gradient
Strength allows uMR Omega
to achieve the shorter TE time
than predicate device in certain
imaging sequence. The system
effectiveness and safety were
verified by the third party
report. |
| Max slew rate | 200T/m/s | 200T/m/s | Same |
| Shielding | active | active | Same |
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR 780 (K191157) | Remark |
| RF system | | | |
| 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 48 | More receive channels allow
uMR Omega to use new high-
channel count and bigger
coverage receive coils. |
| Amplifier peak
power per
channel | 18 kW | 18 kW | Same |
| RF Coils | | | |
| Head & Neck
Coil - 24 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Head Coil - 32 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Temporomandibular Joint Coil -
4 | Yes | Yes | Same |
| Infant Coil - 24 | Yes | Yes | Same |
| Spine Coil - 32 | Yes | Yes | Same |
| Body Array Coil
- 12 | Yes | Yes | Same |
| Cardiac Coil -
24 | Yes | Yes | Same |
| Flex Coil Large - 8 | Yes | Yes | Same |
| Flex Coil Small - 8 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Shoulder Coil -
12 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower Extremity
Coil - 36 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Foot & Ankle
Coil - 24 | Yes | Yes | Same |
| ITEM | Proposed Device
uMR Omega | Predicate Device
uMR 780 (K191157) | Remark |
| Body Array Coil - 24 | Yes | No | The intended use is equivalent
to previously cleared Body
Array Coil -12. More coil
elements in the new coil allow
larger coverage for bigger
patient. |
| Patient table | | | |
| Dimensions | width 640mm,
height 880mm,
length 2620mm | width 640mm,
height 880mm,
length 2620mm | Same |
| Maximum
supported
patient weight | 310 kg | 250kg | Increased table supporting
weight allows bigger and
heavier patient to be scanned. |
| 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 |
| Table 2 Comparison of Application Software Features | | | |
| ITEM | Proposed
Device
uMR Omega | Predicate
Device
uMR 780
(K191157) | Remark |
| Imaging Features | | | |
| Non-uniformity
Correction | Yes | Yes | Same |
| Distortion Correction | Yes | Yes | Same |
| Image Filter | Yes | Yes | Same |
| Water-Fat Imaging
(WFI) | Yes | Yes | Same |
| Susceptibility Weighted
Imaging (SWI) | Yes | Yes | Same |
| Phase Contrast Imaging
(PC) | Yes | Yes | Same |
| Gradient Echo Train
Imaging (GETI) | Yes | Yes | Same |
| Apparent Diffusion
Coefficient (ADC) | Yes | Yes | Same |
| 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. |
| Workflow Features | | | |
| 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. |
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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" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark teal in color and has a white line running vertically through the center.
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Image /page/6/Picture/1 description: The image contains the words "UNITED IMAGING" in bold, dark gray font. To the right of the words is a dark gray logo. The logo is a stylized "U" shape with a white horizontal line through the middle.
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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" shape, which is divided into two halves by a vertical line and has a horizontal line across the top, creating a cross-like shape within the "U". The logo appears to be a dark teal color.
The proposed device and the predicate device are the same in regard to most of application features.
Table 2 below provides a comparison of the application software features of the proposed device in comparison to the predicate device.
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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 text is a stylized "U" symbol, which is also in a bold font. The color of the text and the symbol is a dark teal.
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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 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 in design.
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. Substantial Equivalence
Summary of Non-Clinical Tests:
The following testing was conducted on the uMR Omega Magnetic Resonance Diagnostic Device as the predicate device:
- A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- A 60601-2-33 Ed. 3.2:2015 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
-
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in A Diagnostic Magnetic Resonance Images
-
MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
-
MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- A MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- 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 8-2016, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- A MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
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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 "U" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted.
The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.
Summary of Clinical Tests:
- A volunteer study was used to determine the safety limits associated with gradient-A induced nerve stimulation.
- A Sample clinical images were provided to support the ability of uMR Omega to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
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 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.