The uEXPLORER 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 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, diagnosis, staging, restaging, treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Device Description

The uEXPLORER 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 430ps. It has a 1940mm-long axial field of view (FOV) and the system sensitivity is 191 cps/kBq.

The uEXPLORER 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

The provided text describes the uEXPLORER PET/CT system, but it does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy with human interpretation.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (uMI 780 PET/CT) primarily through:

Comparison of technical specifications: Showing similar physical characteristics and performance specs (e.g., sensitivity, resolution) with the predicate.
Adherence to recognized standards: Confirming compliance with various electrical safety, EMC, performance, software, and biocompatibility standards.
Non-clinical testing: Mentioning dosimetry and system performance tests.
No Clinical Testing: Explicitly stating that "No Clinical Study is included in this submission."

Therefore, based solely on the provided text, I cannot populate all the requested fields, especially those related to clinical performance, human reader studies, or explicit acceptance criteria for diagnostic capability.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily in the form of meeting or exceeding technical specifications and regulatory standards, rather than clinical performance metrics. The reported performance is a comparison to the predicate device and adherence to standards.

Acceptance Criteria Type	Specific Criteria	Reported Device Performance
PET Specification
Sensitivity	≥170cps/kBq (for uEXPLORER)	>/=170cps/kBq (Matches/Exceeds predicate's >/=15cps/kBq)
NECR Peak Value	≥1400kcps@16kBq/cc (for uEXPLORER)	>/=1400kcps@16kBq/cc (Matches/Exceeds predicate's >/=165kcps@16kBq/cc)
Peak True Count Rate	≥4500kcps@28kBq/cc (for uEXPLORER)	>/=4500kcps@28kBq/cc (Matches/Exceeds predicate's >/=500kcps@30kBq/cc)
PET Scatter Fraction	Not explicitly stated as acceptance criteria, but listed in comparison table.	=0.44
Count Rate Bias	Not explicitly stated as acceptance criteria, but listed in comparison table.	=±5%
Axial FWHM@1cm	Not explicitly stated as acceptance criteria, but listed in comparison table.	=3.5mm
Transaxial FWHM@1cm	Not explicitly stated as acceptance criteria, but listed in comparison table.	=3.5mm
Axial FWHM@10cm	Not explicitly stated as acceptance criteria, but listed in comparison table.	=4.0mm
Transaxial FWHM@10cm	Not explicitly stated as acceptance criteria, but listed in comparison table.	=4.0mm
CT Specification
Scan Regime	Continuous Rotation Topo	Continuous Rotation Topo (Same as predicate)
Scan Modes	Axial Scan, Helical Scan	Axial Scan, Helical Scan (Same as predicate)
Z-plane coverage	40mm	40mm (Same as predicate)
Number of detector rows	80	80 (Same as predicate)
Minimum slice thickness	0.5mm	0.5mm (Same as predicate)
Rotation speed	Up to 0.3 sec for 360° rotation	Up to 0.3 sec for 360° rotation (Same as predicate)
Table Maximum Weight	250kg	250kg (Same as predicate)
Safety and Standards
Electrical Safety	Conformance to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012	Claimed conformance and testing conducted in accordance with this standard.
EMC	Conformance to IEC 60601-1-2 Edition 4.0 2014-02	Claimed conformance and testing conducted in accordance with this standard.
Biocompatibility (Patient Contact Materials)	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 as predicate)
Software	Conformance to NEMA PS 3.1-3.20(2011) DICOM, IEC 62304, FDA Guidance for Content of Premarket Submissions for Software, and Cybersecurity Guidance. Software specifications meeting acceptance criteria, V&V acceptable.	Claimed conformance, risk analysis completed, risk control implemented, testing results show software specifications met acceptance criteria, V&V found acceptable. Conforms to Cybersecurity requirements.

Study Proving Device Meets Acceptance Criteria:

The document refers to "Non-Clinical Testing" and adherence to various standards (listed under "Product Particular Standards", "Performance Verification", "Software", etc.) as the primary study or evidence that the device meets its specified (technical) acceptance criteria. There is no specific clinical study proving diagnostic performance.

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

Sample Size: Not applicable as no clinical test set for diagnostic accuracy is described. The "test set" implies phantom data and engineering tests.
Data Provenance: Not specified for non-clinical tests, but typically involves laboratory settings and phantoms.

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

Not applicable as no clinical test set requiring human expert ground truth is described.

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

Not applicable as no clinical test set requiring expert adjudication is described.

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. The document explicitly states: "No Clinical Study is included in this submission." The device is a diagnostic imaging system rather than an AI-assisted diagnostic tool.

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

Not applicable as this is an imaging system, not a standalone AI algorithm for interpretation.

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

For the non-clinical performance verification, the ground truth would be based on physical phantom measurements and engineering specifications (e.g., NEMA NU 2-2012 for PET performance, IEC standards for CT imaging performance). For safety, it would be compliance with defined electrical, EMC and biocompatibility thresholds.

8. The sample size for the training set:

Not applicable/Not provided, as this is an imaging system, not a machine learning algorithm whose performance is being evaluated from a user perspective. The software aspects mentioned are related to system control, reconstruction, and image display, conforming to established software development life cycle standards (IEC 62304).

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

Not applicable/Not provided for the reasons stated above.

Summary

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December 18, 2018

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

Re: K182938

Trade/Device Name: uEXPLORER Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: October 17, 2018 Received: October 23, 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. 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.

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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) 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 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 medical devices and radiation-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,

Hole 2. Mils

for Robert A. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182938

Device Name uEXPLORER

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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.

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See PRA Statement below.

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510(k) SUMMARY

1. Date of Preparation: October 17, 2018

2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com

3. Identification of Proposed Device

Trade Name: uEXPLORER Common Name: Emission Computed Tomography System

Model(s): uEXPLORER

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology

4. Identification of Predicate Device(s)

510(k) Number: K172143 Device Name: uMI 780 Model(s): uMI 780

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology

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5. Device Description

6. Indications for Use

The uEXPLORER 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.

7. Comparison of Technological Characteristics with the Predicate Devices

The uEXPLORER PET/CT has the same indications for use as the predicate device uMI 780 PET/CT. The fundamental scientific technology of the proposed device is same as the predicate device.

Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.

ITEM	Proposed Device	Predicate Device
Product Code	KPS, JAK	KPS, JAK
Regulation No.	21 CFR 892.1200	21 CFR 892.1200
Class	Class II	Class II
Intended Use	The uEXPLORERPET/CT is a diagnosticimaging system thatcombines two existingimaging modalities - PETand CT. The quantitativedistribution informationof PETradiopharmaceuticalswithin the patient bodymeasured by PET canassist healthcareproviders in assessing themetabolic andphysiological functions.CT provides diagnostictomographic anatomicalinformation as well asphoton attenuationinformation for thescanned region. Theaccurate registration andfusion of PET and CTimages providesanatomical reference forthe findings in the PETimages.	The uMI 780 PET/CT isa diagnostic imagingsystem that combinestwo existing imagingmodalities - PET andCT. The quantitativedistribution informationof PETradiopharmaceuticalswithin the patient bodymeasured by PET canassist healthcareproviders in assessingthe metabolic andphysiological functions.CT provides diagnostictomographic anatomicalinformation as well asphoton attenuationinformation for thescanned region. Theaccurate registration andfusion of PET and CTimages providesanatomical reference forthe findings in the PETimages.
	This system is intendedto be operated byqualified healthcareprofessionals to assist inthe detection,localization, diagnosis,staging, restaging,treatment planning andtreatment responseevaluation for diseasesand disorders in, but notlimit to, oncology,cardiology andneurology.	This system is intendedto be operated byqualified healthcareprofessionals to assist inthe detection,localization, diagnosis,staging, restaging,treatment planning andtreatment responseevaluation for diseasesand disorders in, but notlimit to, oncology,cardiology andneurology.
PET Specification
Sensitivity	>/=170cps/kBq	>/=15cps/kBq
NECR PeakValue	>/=1400kcps@16kBq/cc	>/=165kcps@16kBq/cc
Peak True CountRate	>/=4500kcps@28kBq/cc	>/=500kcps@30kBq/cc
PET ScatterFraction	=0.44</td =0.44</td
Count Rate Bias	=±5%</td =±5%</td
AxialFWHM@1cm	=3.5mm</td =3.5mm</td
TransaxialFWHM@1cm	=3.5mm</td =3.5mm</td
AxialFWHM@10cm	=4.0mm</td =4.0mm</td
TransaxialFWHM@10cm	=4.0mm</td =4.0mm</td
CT Specification
Scan Regime	Continuous RotationTopo	Continuous RotationTopo
Scan Modes	Axial ScanHelical Scan	Axial ScanHelical Scan
Z-plane coverage	40mm	40mm
Number ofdetector row	80	80
Minimum slicethickness	0.5mm	0.5mm
Rotation speed	Up to 0.3 sec for 360°rotation	Up to 0.3 sec for 360°rotation
Table Maximum	250kg	250kg
Safety
Electrical Safety	ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012	ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012
EMC	IEC 60601-1-2 Medicalelectrical equipment -Part 1-2: Generalrequirements for basicsafety and essentialperformance - CollateralStandard:	IEC 60601-1-2 Medicalelectrical equipment -Part 1-2: Generalrequirements for basicsafety and essentialperformance - CollateralStandard:Electromagneticdisturbances -Requirements and tests
Biocompatibility	Patient Contact Materialswere tested anddemonstrated nocytotoxicity (ISO 10993-5), no evidence forirritation andsensitization (ISO 10993-10)	Patient ContactMaterials were testedand demonstrated nocytotoxicity (ISO10993-5), no evidencefor irritation andsensitization (ISO10993-10).

Table 1 Comparison of Technological Characteristics

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8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

Non-clinical testing including dosimetry and system performance tests were conducted for the uEXPLORER during the product development.

UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uEXPLORER in accordance with the following standards:

A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General A requirements for basic safety and essential performance - Collateral Standard:

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Electromagnetic disturbances - Requirements and tests

A IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
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)]

Product Particular Standards

IEC 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical A imaging departments - Part 3-5: Acceptance tests -Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
NEMA XR 25-2010: Computed Tomography Dose Check
NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
NEMA XR 29-2013: Standard Attributes on CT Equipment Related to Dose Optimization and Management

Performance Verification

NEMA NU 2-2012 Performance Measurements of Positron Emission Tomographs; A
A Extended Performance Test Report for performance study;
Clinical Evaluation for sample clinical images evaluation; >
AEC Test Report for AEC performance study.

Software

NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM)
IEC 62304: Medical Device Software - software life cycle process
A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Biocompatibility

ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -A Part 10: Tests for irritation and skin sensitization
A ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity

Other Standards and Guidances

ISO 14971: Medical Devices Application of risk management to medical devices A
A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation

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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is also in a bold font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.

A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
A Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

Software Verification and Validation

Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.

The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.

UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.

Clinical Testing

No Clinical Study is included in this submission.

Summarv

The features described in this premarket submission are supported with the results of the testing mentioned above, the uEXPLORER was found to have a safety and effectiveness profile that is similar to the predicate device.

9. Conclusions

Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness 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. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

N/A