The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce 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. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healtheare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Description

The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.

AI/ML Overview

The provided text does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria in the way a clinical performance study would for an AI-powered diagnostic device.

Instead, the document is a 510(k) summary for a combined MRDD and PET scanner (uPMR 790), asserting substantial equivalence to a predicate device (GE Healthcare's SIGNA PET/MR, K142098). The focus is on demonstrating that the new device has similar technological characteristics and performs as expected, not on specific diagnostic performance metrics (e.g., sensitivity, specificity) against a clinical ground truth.

Here's what can be inferred from the provided text regarding acceptance and testing:

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

The document lists various non-clinical standards and tests that were conducted. These standards serve as "acceptance criteria" in the sense that the device must comply with them to be considered safe and effective. The "reported device performance" is a general statement that the device "performs as expected" and the "test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices." No specific quantitative performance metrics like sensitivity, specificity, or AUC are provided as acceptance criteria or results.

Acceptance Criterion (Standard/Test)	Reported Device Performance (Implied)
ES60601-1:2005/(R)2012 (Medical Electrical Equipment - Basic Safety)	Complies (performs as expected)
IEC 60601-1-2 Ed. 4.0 2014 (EMC)	Complies (performs as expected)
60601-2-33 Ed. 3.1:2013 (MR Equipment Safety)	Complies (performs as expected)
IEC 60825-1 Ed. 2.0 2007-03 (Laser Safety)	Complies (performs as expected)
ISO 10993-5 (In Vitro Cytotoxicity)	Complies (performs as expected)
ISO 10993-10 (Irritation & Skin Sensitization)	Complies (performs as expected)
MS 1-2008(R2014) (SNR in MR Images)	Complies (performs as expected)
MS 2-2008(R2014) (2D Geometric Distortion in MR)	Complies (performs as expected)
MS 3-2008(R2014) (Image Uniformity in MR)	Complies (performs as expected)
MS 4-2010 (Acoustic Noise in MR)	Complies (performs as expected)
MS 5-2010 (Slice Thickness in MR)	Complies (performs as expected)
MS 6-2008(R2014) (SNR & Uniformity for Single-Channel Coils)	Complies (performs as expected)
MS 8-2008 (SAR for MR Systems)	Complies (performs as expected)
MS 9-2008(R2014) (Phased Array Coils for MR)	Complies (performs as expected)
NEMA NU 2-2012 (PET Performance Measurements)	Complies (performs as expected)
Overall Clinical Image Quality	"Sample clinical images were provided to support the ability of uPMR 790 to generate diagnostic quality images."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the "sample clinical images" provided.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only mentions "Sample clinical images were provided."

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

This information is not provided. The phrase "diagnostic quality images" implies expert evaluation, but the number or qualifications of experts are not stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not an AI-powered diagnostic device, but rather a combined imaging system (PET/MR). Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not conducted. The study is about the performance of the imaging device itself.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is an imaging device, not an algorithm. The "standalone" performance here refers to the device's ability to produce images according to technical standards.

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

For the clinical images, the "ground truth" seems to be implied by the assessment of "diagnostic quality images." This would likely involve expert interpretation, but explicit details (like expert consensus, pathology, or outcomes) are not given. For the non-clinical tests, the ground truth is against specific engineering and medical device standards (e.g., NEMA NU 2-2012 for PET performance, NEMA MS series for MR performance).

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm that requires a training set. It is a hardware imaging system.

9. How the ground truth for the training set was established:

Not applicable, as this device is not an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a stylized depiction of a human figure, while the FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang QM & RA VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA

February 27, 2019

Re: K183014

Trade/Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO Dated: January 22, 2019 Received: January 23, 2019

Dear Shumei Wang:

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

{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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K183014

Device Name uPMR 790

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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" symbol, which is also in a bold, sans-serif font. The color of the text and the "U" symbol is a dark teal.

510 (k) SUMMARY

K183014

1. Date Prepared [21 CFR 807.92(a)(1)] October 29, 2018

2. General Information [21 CFR 807.92(a)(1)]

Manufacturer:	Shanghai United Imaging Healthcare Co., Ltd2258 Chengbei Rd., Jiading District, Shanghai, 201807
Contact Person:	Shumei WANGQM&RA VPTel: +86 (21) 67076888-6776Fax: +86-021-67076889Email: shumei.wang@united-imaging.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	uPMR 790
Common Name:	Tomographic Imager Combining Emission ComputedTomography with Nuclear Magnetic Resonance
Model:	uPMR 790
Product Code:	OUO
Regulation Number:	892.1200
Device Class:	II

4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification of predicates device within this submission is as follow:

Predicate Device
Manufacturer:	GE Healthcare
Device Name:	SIGNA PET/MR
Product Code:	OUO
Device Class:	II
Regulation Number:	21 CFR 892.1200
FDA 510 (k) #:	K142098

5. Device Description [21 CFR 807.92(a)(4)]

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark blue with a white vertical line running through the center. The logo is simple and modern.

6. Intended Use [21 CFR 807.92(a)(5)]

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce 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. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

7. Technological Characteristic [21 CFR 807.92(a)(6)]

The uPMR 790 has the similar major technological characteristics as the predicate device. The differences from the predicate device including high order shimming configuration, interventional usage, RFPA power, geometrical dimensions of PET detector, and external triggering function are discussed in the comparison table in this submission. The same scientific technology theory, similar physical design, same coil applications and functionalities are applied to both the uPMR 790 and predicate device. The technical characteristic differences do not affect the safety and effectiveness of the uPMR 790 for intended use.

{5}------------------------------------------------

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 is dark gray. The logo is simple and modern in design.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

Summary of Non-Clinical Tests:

The following testing was conducted on the uPMR 790 system:

A 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, 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. 3.1:2013, 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
A 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 Diagnostic Magnetic Resonance Images
MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
A MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic A 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
A MS 8-2008, 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
A NEMA NU 2-2012 Performance Measurements of Positron Emission Tomography

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.

Summarv of Clinical Tests:

Sample clinical images were provided to support the ability of uPMR 790 to generate diagnostic quality images.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" 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 symbol is a dark teal.

9. Conclusion [21 CFR 807.92(b)(3)]

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 uPMR 790 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

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.