The uMI 780 PET/CT is a diagnostic imaging system that combines two existing imaging modalities -PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Device Description

The uMI 780 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy. The PET system has time-of-flight capability with a timing resolution of 520ps. It has a 300mm-long axial field of view (FoV) and a system sensitivity higher than 15cps/kBq.

The uMI 780 PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the uMI 780 PET/CT System, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (Siemens Biograph mCT and mCT Flow PET/CT Scanners). Therefore, the "study" referred to here is primarily a set of non-clinical tests to verify performance and compliance with recognized standards, rather than a clinical trial directly demonstrating efficacy in a patient population.

1. Table of Acceptance Criteria (for key PET and CT specifications) and Reported Device Performance

The device performance is compared directly against the predicate device, which inherently sets the acceptance criteria based on established performance within the industry.

Item	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (uMI 780)
PET Specification
Sensitivity	≥ 9.4 cps/kBq	≥ 15 cps/kBq
NECR Peak Value	≥ 165 kcps @ 28 kBq/cc	≥ 165 kcps @ 16 kBq/cc
Peak True Count Rate	≥ 575 kcps @ 40 kBq/cc	≥ 500 kcps @ 30 kBq/cc
PET Scatter Fraction	(No explicit value, implies comparable to predicate)	≤ 40%
Count Rate Bias	(No explicit value, implies comparable to predicate)	≤ ±5%
Axial FWHM@1cm Axial FWHM@10cm	(No explicit value, implies comparable to predicate)	≤ 3.5mm ≤ 4.0mm
Transaxial FWHM@1cm Transaxial FWHM@10cm	(No explicit value, implies comparable to predicate)	≤ 3.5mm ≤ 4.0mm
CT Specification
Scan Regime	Continuous Rotation	Continuous Rotation
Scan Modes	Topo, Axial Scan, Helical Scan	Topo, Axial Scan, Helical Scan
Z-plane coverage	38.4mm	40mm
Number of detector row	64	80
Minimum slice thickness	0.6mm	0.5mm
Rotation speed	Up to 0.3 sec for 360° rotation	Up to 0.3 sec for 360° rotation
Table Maximum table load	227kg	250kg
Safety and Compliance
Biocompatibility	Comply with ISO 10993-5, ISO 10993-10	Comply with ISO 10993-5, ISO 10993-10
Electrical Safety	Comply with ES 60601-1	Comply with ES 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2

2. Sample Size Used for the Test Set and Data Provenance

The document states that "No clinical study is included in this submission" (page 6). Therefore, there is no patient-based test set in the traditional sense for clinical performance. The testing was primarily non-clinical performance testing of the device's physical and technical specifications.

Test Set: Not applicable in the context of human subjects or clinical data. The "test set" consisted of the device itself and phantoms used for performance measurements.
Data Provenance: The tests conducted (e.g., NEMA NU 2:2012) are standardized laboratory or bench tests. The exact country of origin for the testing itself is not explicitly stated, but the manufacturer is based in Shanghai, China. The data is retrospective in the sense that it evaluates the device's technical specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this was primarily non-clinical performance testing of hardware and software specifications, there were no experts establishing ground truth for a clinical test set. The "ground truth" for these tests are the defined physical and electrical standards and the specifications measured against those standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No MRMC study was done, as explicitly stated, "No clinical study is included in this submission." This device is a PET/CT scanner, not an AI-powered diagnostic algorithm in the typical sense that would necessitate a human-in-the-loop study for performance improvement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The document does not describe the evaluation of a standalone algorithm for diagnostic performance. The device itself is an imaging system. The performance testing was for the overall system's technical specifications (e.g., image quality, sensitivity, safety).

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" was established by recognized industry and international standards for medical imaging devices. These include:

AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012 (Electrical safety)
IEC 60601-1-3: Edition 2.1 (Radiation protection)
IEC 60601-2-44: Edition 3.0 (X-ray equipment for CT)
IEC 60601-1-2: Edition 3 (Electromagnetic compatibility)
IEC 60825-1: Edition 2.0 (Laser safety, if applicable)
NEMA 61223-3-5: First edition (Evaluation of the imaging performance of CT medical x-ray equipment)
NEMA NU 2:2012 (Performance Measurements of Positron Emission Tomography Scanners)
ISO 10993-10: Third Edition (Biological evaluation of medical devices - irritation and skin sensitization)
ISO 10993-5: Third edition (Biological evaluation of medical devices - tests for in vitro cytotoxicity)
NEMA XR 25: 2010 (Computed Tomography Dose Check)
NEMA XR 28:2013 (Performance Measurements of Computed Tomography Systems with Dose Modulation)
NEMA XR 29:2013 (Standard for the display of Imaging Information for Digital Mammography) (Likely an error, as this is a PET/CT system, not mammography, but listed in the document).

8. The Sample Size for the Training Set

Not applicable. This document does not describe a machine learning algorithm that underwent a training phase with a specific dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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

Re: K172143

Trade/Device Name: uMI 780 PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK, Dated: March 10, 2018 Received: March 13, 2018

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

April 13, 2018

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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'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

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Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drup Administration Indications for Use

Form Approved:OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below

510(k) Number( if known)

K172143

Device Name

uMI 780 PET/CT System

Indications for Use (Describe):

Type of use:

Precription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (Part 21 CFR 801 Subpart D)

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."

FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740 FF

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SECTION 16 510(k) Summary

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510(k) SUMMARY

1. Date of Preparation: March 9, 2018

2. Sponsor Identification

Client Name:	Shanghai United Imaging Healthcare Co.,Ltd.
Client Address:	NO.2258 Chengbei Road, Jiading District, Shanghai,China
EstablishmentRegistration Number:	Not yet registered
Contact Person:	Wang Shumei
Position:	QM&RA VP
Tel:	+86-21-67076888-6776
Fax:	+86-21-67076889
Email:	shumei.wang@united-imaging.com

3. Identification of Proposed Device

Model(s):	uMI 780
Trade Name:	uMI 780
Common Name:	Positron Emission Tomography andComputed Tomography System
Classification Name:	Emission Computed Tomography System per 21 CFR 892.1200Computed Tomography X-Ray System per 21 CFR 892.1750
Regulation Number:	21 CFR 892.1200
Product Code:	KPS and JAK
Review Panel:	Radiology
Classification:	Class II

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Proposed Device Description 4.

5. Intended Use Statement of Proposed Device

The uMI 780 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and

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treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Identification of Predicate Device(s) 6.

510(k) Number:	K151486
Product Name:	Positron Emission Tomography (PET) SystemComputed Tomography (CT) System
Model Name:	Biograph mCT and mCT Flow PET/CT Scanners

7. Non-clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Recognition Number 19-4:AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012
Recognition Number 12-269:IEC 60601-1-3: Edition 2.1
Recognition Number 12-257:IEC 60601-2-44: Edition 3.0
Recognition Number 19-1:IEC 60601-1-2: Edition 3
Recognition Number 12-273:IEC 60825-1:Edition 2.0
Recognition Number 12-270:NEMA 61223-3-5: First edition
Recognition Number 12-265:NEMA NU 2:2012
Recognition Number 2-174:ISO 10993-10:Third Edition
Recognition Number 2-245:ISO 10993-5:Third edition
Recognition Number 12-225:NEMA XR 25: 2010
Recognition Number 12-287:NEMA XR 28:2013
NEMA XR 29:2013

8. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Substantial Equivalence Comparison

Table 1 Comparison of Technology Characteristics
--------------------------------------------------	--	--	--	--	--	--

Item	Proposed Device(s)	Predicate Device(s)
Product Code	KPS,JAK	KPS,JAK
Regulation No.	21 CFR 892.1200	21 CFR 892.1200
Class	II	II
Intended Use	The uMI 780 PET/CT is adiagnostic imaging system thatcombines two existing imagingmodalities - PET and CT. Thequantitative distributioninformation of PETradiopharmaceuticals within thepatient body measured by PET canassist healthcare providers inassessing the metabolic andphysiological functions. CTprovides diagnostic tomographicanatomical information as well asphoton attenuation information forthe scanned region. The accurateregistration and fusion of PET andCT images provides anatomicalreference for the findings in thePET images.This system is intended to beoperated by qualified healthcareprofessionals to assist in thedetection, localization, diagnosis,staging, restaging, treatmentplanning and treatment responseevaluation for diseases anddisorders in, but not limit to,oncology, cardiology andneurology.	The Siemens Biograph mCT systemsare combined X-Ray ComputedTomography (CT) and PositronEmissionTomography (PET) scanners thatprovide registration and fusion ofhigh resolution physiologic andanatomic information.The CT component produces cross-sectional images of the body bycomputer reconstruction of X-Raytransmission data from either thesame axial plane taken at differentangles or spiral planes taken atdifferent angles. The PET subsystemimages and measures the distributionof PET radiopharmaceuticals inhumans for the purpose ofdetermining various metabolic(molecular) and physiologicfunctions within the human body andutilizes the CT for fast attenuationcorrection maps for PET studies andprecise anatomical reference for thefused PET and CT images.The system maintains independentfunctionality of the CT and PETdevices, allowing for single modalityCT and / or PET diagnostic imaging.These systems are intended to beutilized by appropriately trainedhealth care professionals to aid indetecting, localizing, diagnosing,staging and restaging of lesions,tumors, disease and organ functionfor the evaluation of diseases anddisorders such as, but not limited to,cardiovascular disease, neurologicaldisorders and cancer. The imagesproduced by the system can also beused by the physician to aid inradiotherapy treatment planning andinterventional radiology procedures.
Item	Proposed Device(s)	Predicate Device(s)
PET Specification
Sensitivity	>/=15cps/kBq	>/=9.4cps/kBq
NECR Peak Value	>/=165kcps@16kBq/cc	>/=165 kcps@28kBq/cc
Peak True Count Rate	>/=500kcps@30kBq/cc	>/=575kcps@40kBq/cc
PET Scatter Fraction	=0.44</td =40%</td
Count Rate Bias	= ±5%</td = ±5%</td
Axial FWHM@1cm	=3.5mm</td =6.0mm</td
Transaxail FWHM@1cm	=3.5mm</td =7.3mm</td
Axial FWHM@10cm	=4.0mm</td =6.6mm</td
Transaxial FWHM@10cm	=4.0mm</td =7.5mm</td
CT Specification
Scan Regime	Continuous Rotation	Continuous Rotation
Scan Modes	TopoAxial ScanHelical Scan	TopoAxial ScanHelical Scan
Z-plane coverage	40mm	38.4mm
Number of detector row	80	64
Minimum slice thickness	0.5mm	0.6mm
Rotation speed	Up to 0.3 sec for 360 °rotation	Up to 0.3 sec for 360 °rotation
Table Maximum table load	250kg	227kg
Safety
Biocompatibility	Comply with ISO 10993-5,ISO 10993-10	Comply with ISO 10993-5,ISO 10993-10
Electrical Safety	Comply with ES 60601-1	Comply with ES 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2

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Testing in accordance with the FDA standards for ionizing radiation emitting products and equipment with laser lights were passed and the test results were documented.

Performance testing in accordance with NEMA NU2:2012 was conducted and met the predetermined acceptance values. The test results were documented.

The device's labeling contains the operator's manuals for the system and software operations, the technical instructions, and necessary labels for safe and effective use of the device.

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10. Substantially Equivalent (SE) Conclusion

The uMI 780 PET/CT system is intended for the same use as and functions in a similar manner to the predicate device. With the proof of conformance to applicable standards, successful completion of software validation and performance test results presented in this submission, it is concluded that the uMI 780 PET/CT system is as safe, effective and is substantially equivalent to the predicate device.

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.