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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the uMR Omega Magnetic Resonance Diagnostic Device. It compares the proposed device to a predicate device (uMR 780) to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

The document focuses on technological characteristics, safety, and effectiveness comparisons to a previously cleared device. It does not contain information about acceptance criteria in the typical sense of quantitative performance metrics for disease detection or diagnosis, nor does it describe a study specifically designed to meet such criteria. Therefore, most of the requested information cannot be extracted from this document.

However, based on the non-clinical and clinical tests mentioned, some inferences can be made, though they do not directly answer all the questions.

Information that CANNOT be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the uMR Omega. It primarily focuses on showing that its technical specifications and image quality are comparable to or better than the predicate device.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is a magnetic resonance diagnostic device, not an AI-assisted diagnostic tool in the sense of aiding human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a diagnostic imaging device, not primarily an AI algorithm for interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any performance evaluation.
The sample size for the training set: Not applicable, as this is primarily a hardware/software system for imaging, not a machine learning algorithm that requires a "training set" in the conventional sense.
How the ground truth for the training set was established: Not applicable for the reasons above.

Information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

As mentioned, there isn't a table for diagnostic performance acceptance criteria. However, the document does list technical parameters and safety compliance as criteria. The "Reported Device Performance" here would refer to the device meeting these technical and safety standards, and demonstrating image quality comparable to the predicate.

Acceptance Criteria Category	Specific Criteria (Inferred/Stated)	Reported Device Performance (Inferred/Stated)
Safety Standards	Compliance with: - ES60601-1 (Medical Electrical Equipment - Basic Safety) - IEC 60601-1-2 (EMC)- IEC 60601-2-33 (MR Equipment Particular Requirements)- IEC 60825-1 (Laser Safety)- ISO 10993-5 (Cytotoxicity)- ISO 10993-10 (Irritation & Sensitization)	Demonstrated compliance with all listed standards.- Patient-contact materials tested and showed no cytotoxicity, irritation, or sensitization.
Image Quality (Non-clinical)	Compliance with standards for: - Signal-to-Noise Ratio (SNR) (MS 1, 6)- Geometric Distortion (MS 2)- Image Uniformity (MS 3, 6)- Slice Thickness (MS 5)	Testing based on NEMA Standards (MS 1, 2, 3, 5, 6, 9) was performed. (The document states: "The test results demonstrated that the device performs as expected...") The technical specifications like magnet homogeneity (e.g., 2.3ppm @ 50cm DSV) and gradient amplitude (45mT/m) are improvements or comparable to the predicate and contribute to image quality.
Physical Parameters	- Field Strength: 3.0 Tesla- Magnet Type: Superconducting- Patient Bore: 75cm- Max Gradient Amplitude: 45mT/m- Max Slew Rate: 200T/m/s- Receive Channels: Up to 96- Max Support Patient Weight: 310 kg	- 3.0 Tesla (Met)- Superconducting (Met)- 75cm (Met; larger than predicate 65cm)- 45mT/m (Met; higher than predicate 42mT/m)- 200T/m/s (Met; same as predicate)- Up to 96 (Met; more than predicate 48)- 310kg (Met; increased from predicate 250kg)
Clinical Performance	Ability to generate diagnostic quality images.	- "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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for clinical image review: Not specified, only "Sample clinical images were provided".
Data provenance: Not specified. The sponsor is Shanghai United Imaging Healthcare Co., Ltd. in China, but the origin of clinical images is not stated. It mentions a "volunteer study" but the number of volunteers is not specified.
Retrospective or prospective: Not specified for the clinical images, though the "volunteer study" would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not specified. The document states "when interpreted by a trained physician" in its Indications for Use, but this is general for MRDDs, not for the specific evaluation study.
Qualifications of experts: Not specified beyond "trained physician."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests (e.g., SNR, uniformity), the "ground truth" is based on adherence to NEMA standards and physical measurements.
For the "clinical images," the document only states they were provided to "support the ability... to generate diagnostic quality images." It does not specify how "diagnostic quality" was formally assessed or what independent ground truth (e.g., correlating with pathology, outcomes, or expert consensus) was used to validate the diagnostic information derived from these images.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K193200

Device Name uMR Omega

Indications for Use (Describe)

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

K193200

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

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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.

7. Technological Characteristic

The differences from the predicate device are discussed in the comparison table in this submission is added below.

ITEM	Proposed DeviceuMR Omega	Predicate DeviceuMR 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 ForUse	The uMR Omegasystem is indicatedfor use as a magneticresonancediagnosticdevice(MRDD)thatproducessagittal,transverse, coronal,and oblique crosssectional images,and spectroscopicimages , and thatdisplay internalanatomical structureand/or function ofthe head, body andextremities.These images andthe physicalparameters derived	The uMR 780system is indicatedfor use as a magneticresonancediagnostic device(MRDD) thatproduces sagittal,transverse, coronal,and oblique crosssectional images,and spectroscopicimages, and thatdisplay internalanatomical structureand/or function ofthe head, body andextremities.These images andthe physicalparameters derived	Same
ITEM	Proposed DeviceuMR Omega	Predicate DeviceuMR 780 (K191157)	Remark
	from the images	from the images
	when interpreted bya trained physician	when interpreted bya trained physician
	yield informationthat may assist thediagnosis. Contrastagents may be useddepending on theregion of interest ofthe scan.	yield informationthat may assist thediagnosis. Contrastagents may be useddepending on theregion of interest ofthe scan.
Magnet system
Field Strength	3.0 Tesla	3.0 Tesla	Same
Type of Magnet	Superconducting	Superconducting	Same
Patient-accessible boredimensions	75cm	65cm	Larger bore size for patientscomfort during scanningwithout compromising otherimaging functions.
Type ofShielding	Actively shielded,OIS technology	Actively shielded,OIS technology	Same
MagnetHomogeneity	2.3ppm @ 50cm DSV0.8ppm @ 45cm DSV0.38ppm @ 40cmDSV0.08ppm @ 30cmDSV0.02ppm @ 20cmDSV0.002ppm @ 10cmDSV	2.4ppm @ 50cm DSV0.8ppm @ 45cm DSV0.39ppm @ 40cmDSV0.11ppm @ 30cmDSV0.038ppm @ 20cmDSV0.002ppm @ 10cmDSV	In order to support larger boresize, uMR Omega system has abigger magnet design.Compared with the predicatedevice, the size and 5-gaussline range is larger. Thehomogeneity of the magnet isequal or better at typical DSVsthus clinical scanning is notlimited compared to predicatedevice.
Gradient system
Max gradientamplitude	45mT/m	42mT/m	The higher Maximum GradientStrength allows uMR Omegato achieve the shorter TE timethan predicate device in certainimaging sequence. The systemeffectiveness and safety wereverified by the third partyreport.
Max slew rate	200T/m/s	200T/m/s	Same
Shielding	active	active	Same
ITEM	Proposed DeviceuMR Omega	Predicate DeviceuMR 780 (K191157)	Remark
RF system
Resonantfrequencies	128.23 MHz	128.23 MHz	Same
Number oftransmitchannels	2	2	Same
Number ofreceive channels	Up to 96	Up to 48	More receive channels allowuMR Omega to use new high-channel count and biggercoverage receive coils.
Amplifier peakpower perchannel	18 kW	18 kW	Same
RF Coils
Head & NeckCoil - 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 ExtremityCoil - 36	Yes	Yes	Same
Small Loop Coil	Yes	Yes	Same
Foot & AnkleCoil - 24	Yes	Yes	Same
ITEM	Proposed DeviceuMR Omega	Predicate DeviceuMR 780 (K191157)	Remark
Body Array Coil- 24	Yes	No	The intended use is equivalentto previously cleared BodyArray Coil -12. More coilelements in the new coil allowlarger coverage for biggerpatient.
Patient table
Dimensions	width 640mm,height 880mm,length 2620mm	width 640mm,height 880mm,length 2620mm	Same
Maximumsupportedpatient weight	310 kg	250kg	Increased table supportingweight allows bigger andheavier patient to be scanned.
Accessories
Vital SignalGating	ECG, Peripheral PulseGating, RespiratoryGating	ECG, Peripheral PulseGating, RespiratoryGating	Same
Safety
Electrical Safety	Comply withES60601-1	Comply withES60601-1	Same
EMC	Comply withIEC60601-1-2	Comply withIEC60601-1-2	Same
Max SAR forTransmit Coil	Comply with IEC60601-2-33	Comply with IEC60601-2-33	Same
Max dB/dt	Comply with IEC60601-2-33	Comply with IEC60601-2-33	Same
Biocompatibility	Patient ContactMaterials weretested anddemonstrated nocytotoxicity (ISO10993-5), noevidence forirritation andsensitization (ISO10993-10)	Patient ContactMaterials weretested anddemonstrated nocytotoxicity (ISO10993-5), noevidence forirritation andsensitization (ISO10993-10)	Same
Table 2 Comparison of Application Software Features
ITEM	ProposedDeviceuMR Omega	PredicateDeviceuMR 780(K191157)	Remark
Imaging Features
Non-uniformityCorrection	Yes	Yes	Same
Distortion Correction	Yes	Yes	Same
Image Filter	Yes	Yes	Same
Water-Fat Imaging(WFI)	Yes	Yes	Same
Susceptibility WeightedImaging (SWI)	Yes	Yes	Same
Phase Contrast Imaging(PC)	Yes	Yes	Same
Gradient Echo TrainImaging (GETI)	Yes	Yes	Same
Apparent DiffusionCoefficient (ADC)	Yes	Yes	Same
Phase SensitiveInversion Recovery(PSIR)	Yes	No	PSIR is substantially equivalentto conventional inversion recovery (IR) and uses phase sensitive reconstruction to produce real imageinstead of magnitude image.
Computed DWI (cDWI)	Yes	No	cDWI calculates and outputsdiffusion-weighted images withuser-input b-values and issubstantially equivalent toconventional DWI.
Susceptibility WeightedImaging Plus (SWI+)	Yes	No	SWI+ is substantially equivalentto SWI and uses multi-echo inacquisition and reconstructioninstead of single echo.
Workflow Features
Easy Scan	Yes	No	Easy Scan feature allowsautomatic slice positioning forhead, cardiac, c-spine and kneeimaging. The positioning can alsobe adjusted manually from user.The final positioning effect isequivalent to manual operationwithout 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.

Regulation Number and Section

§ 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.