The uMI Panorama 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 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 treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.

This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

Device Description

The proposed device uMI Panorama combines a 280 or 350 mm axial field of view (FOV) PET and 160-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET system. CT system, patient table, power distribution unit, control and reconstruction system (host, monitor, and reconstruction computer, system software, reconstruction software), vital signal module and other accessories.

The uMI Panorama has been previously cleared by FDA via K223325. The mainly modifications performed on the uMI Panorama (K223325) in this submission are due to the algorithm update of uExcel Focus (also named OncoFocus) and the addition of uKinetics. This time, uExcel Focus adds deep learning technology based on the original technology and could be performed as intended. uKinetics is a new function. which is used to generate both indirect and direct parametric images.

AI/ML Overview

The provided text describes a 510(k) summary for the uMI Panorama PET/CT system, with specific modifications related to the uExcel Focus and uKinetics features. While it outlines general performance evaluations, it does not contain the detailed, quantitative acceptance criteria and the full study data typically found in a clinical study report. It primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer some details and present them in the requested format, clearly indicating where implicit understanding or lack of specific data exists.

Here's an attempt to extract and structure the information as requested, with explicit notes about missing details:

Acceptance Criteria and Device Performance for uMI Panorama (uExcel Focus and uKinetics updates)

The performance data provided primarily aims to demonstrate substantial equivalence to the predicate device (uMI Panorama K223325) for specific new features: uExcel Focus and uKinetics. The studies performed were "bench tests" and a "clinical image evaluation."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in numerical thresholds but rather describes the intended outcome of the features. The "reported device performance" are qualitative statements about the observed effects.

Feature	Category	Acceptance Criteria (Implied/Qualitative)	Reported Device Performance (Qualitative)
uExcel Focus	Respiratory Motion Correction	Reduce respiratory motion effects. Improve accuracy of SUV and lesion volume.	"The performance evaluation showed that uExcel Focus could reduce respiratory motion effects and improve the accuracy of SUV and lesion volume in comparison with no motion correction." "Clinical evaluation shows that all images produced by uMI Panorama with uExcel Focus are sufficient for clinical diagnosis and uExcel Focus can reduce attenuation correction artifacts and improve PET-CT alignment."
uKinetics	Parametric Image Generation	Provide quantitatively accurate parametric images.	"Bench test showed that uKinetics can provide quantitatively accurate parametric images."

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

Sample Size (Test Set): Not explicitly stated. For uExcel Focus, "images were compared," and for uKinetics, "Bias of area under curve (AUC) of the estimated image-derived input function (IDIF)" and "Bias of Ki and intercept in the hot spheres in the IO phantom" and "Coefficient of variation (CoV) of the background region in the IQ phantom" were assessed. This suggests phantom data for verification. The "clinical image evaluation" involved two physicians evaluating "images," but the number of patient cases or images is not provided.
Data Provenance: Not explicitly stated. The manufacturer is based in Shanghai, China. The nature of the "clinical image evaluation" (retrospective or prospective) is not specified, but it implies real patient data. Phantom data is generated in a controlled environment.

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

Number of Experts: For the "Clinical Image Evaluation" of uExcel Focus, Two American board-certified nuclear medicine physicians were involved.
Qualifications of Experts: "American board-certified nuclear medicine physicians." No specific experience duration (e.g., "10 years of experience") is mentioned.

4. Adjudication Method for the Test Set

For the "Clinical Image Evaluation" of uExcel Focus, the physicians evaluated images "independently." The document does not specify an adjudication method (e.g., 2+1, 3+1, consensus reading by a third party if there was disagreement). It merely states they evaluated independently.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a formal MRMC comparative effectiveness study, as typically understood for quantifying human reader improvement, was not explicitly described. The "Clinical Image Evaluation" was a "blind comparison" where two nuclear medicine physicians independently evaluated images from the uMI Panorama with/without uExcel Focus. This setup is a prerequisite for an MRMC study, but the document only reports a qualitative conclusion ("sufficient for clinical diagnosis," "can reduce artifacts and improve alignment") rather than a statistical analysis of reader performance improvement (e.g., AUC, sensitivity, specificity) with AI assistance versus without.
Effect Size of Human Reader Improvement: Not reported.

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

The performance descriptions for both uExcel Focus (e.g., "reduce respiratory motion effects and improve the accuracy of SUV and lesion volume") and uKinetics (e.g., "provide quantitatively accurate parametric images") appear to describe the algorithm's inherent performance as measured through "bench testing" (which often involves phantoms or simulated data) or direct analysis of image metrics.
Thus, yes, aspects of standalone performance were evaluated for both features, particularly uKinetics which focuses on quantitative accuracy of derived parameters. uExcel Focus also had non-clinical tests verifying its effects on SUV and volume accuracy.

7. The Type of Ground Truth Used

For uExcel Focus (non-clinical/bench testing): The ground truth metrics were likely derived from known phantom configurations where true SUV, lesion volume, and motion scenarios are controlled or modeled to allow for comparison against system output (e.g., known phantom dimensions and activity concentrations).
For uKinetics (non-clinical/bench testing): Ground truth was based on phantom properties (e.g., "hot spheres in the IO phantom," "background region in the IQ phantom") and potentially theoretical or simulated models for IDIF, Ki, and intercept values given known input.
For uExcel Focus (clinical image evaluation): The "ground truth" for clinical sufficiency and artifact reduction appears to be expert consensus/opinion by the two American board-certified nuclear medicine physicians, rather than pathology or long-term clinical outcomes data. They judged if the images were "sufficient for clinical diagnosis."

8. The Sample Size for the Training Set

Not provided. The document states that uExcel Focus "adds deep learning technology based on the original technology," which implies the use of a training set. However, the size and characteristics of this training set are not disclosed in this 510(k) summary.

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

Not provided. Given the use of deep learning for uExcel Focus, a method to establish ground truth for training data would be crucial (e.g., expert annotations, simulated data, or other validated methods). This detail is not included in the provided text.

Summary

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October 3, 2023

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

Re: K232712

Trade/Device Name: uMI Panorama Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: September 5, 2023 Received: September 5, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality

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Indications for Use

Submission Number (if known)

K232712

Device Name

uMI Panorama

Indications for Use (Describe)

Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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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510 (K) SUMMARY

1. Date of Preparation September 5, 2023

Sponsor Identification 2.

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

Contact Person: Xin GAO Position: Regulatory Affair Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com

3. Identification of Proposed Device

Device Name: uMI Panorama Common Name: Positron Emission Tomography and Computed Tomography Systems Model(s): uMI Panorama 28, uMI Panorama 35

Regulatory Information

Regulation Number: 21 CFR 892.1200, 21 CFR 892.1750 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

Identification of Primary/Reference Device(s) 4.

Predicate Device

510(k) Number: K223325 Device Name: uMI Panorama Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

Reference Device

510(k) Number: K173578 Device Name: Biograph mCT and MCT Flow PET/CT Scanners

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Image /page/4/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 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, and the use of bold text and a strong color palette makes it easily recognizable.

Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

5. Device Description:

6. Indications for Use

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of two parts: the text "UNITED IMAGING" in a bold, sans-serif font, and a stylized letter "U" to the right. The letter "U" is formed by two thick vertical lines with a horizontal line connecting them at the top, creating a shape that resembles a shield or emblem.

Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

7. Comparison of Technological Characteristics with the Predicate Device

uMI Panorama employs the same basic operating principles and fundamental technologies, and has the same indications for use as the predicate device. A comparison between the technological characteristics of proposed and predicate devices is provided as below.

ITEM	Proposed DeviceuMI Panorama	Predicate DeviceuMI Panorama (K223325)
Patient bore size	760mm	760mm
PET System	Scintillator material: LYSO	Scintillator material: LYSO
	Number of detector rings:	Number of detector rings:
	• 96 (uMI Panorama 28)	• 96 (uMI Panorama 28)
	• 120 (uMI Panorama 35)	• 120 (uMI Panorama 35)
	Axial FOV:	Axial FOV:
	• 280mm (uMI Panorama 28)	• 280mm (uMI Panorama 28)
	• 350mm (uMI Panorama 35)	• 350mm (uMI Panorama 35)
CT System	uCT ATLAS Astound (K223028)	uCT ATLAS Astound (K223028)
Maximum table load	318kg	318kg
Advanced Feature
uExcel Focus	Yes	Yes
uKinetics	Yes	No

uMI Panorama's technological characteristics do not raise new safety and effectiveness concerns.

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 image performance tests were conducted for the uMI Panorama to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device.

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

Electrical Safety and Electromagnetic Compatibility (EMC)

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Image /page/6/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.

ANSI/AAMIES60601-1: 2005/ (R) > 2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012)[IncludingAmendment2(2 021)]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC60601-1-2:2014+A1:2020, Medical electrical equipment Part 1-2: General A requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
A IEC 60601-1-3: 2008+AMD1:2013+A2:2021, Edition 2.2, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
A IEC 60601-2-44:2009+A1:2012+A2:2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-rav equipment for computed tomography
A IEC 60825-1: 2014, Edition 3.0, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-6:2010+A1:2013+A2:2020, Edition 3.2, Medical electrical A equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
A IEC 62304:2006+AMD1:2015 CSV Consolidated version, Medical device software - Software life cycle processes
A NEMA XR 25-2019, Computed Tomography Dose Check
A NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT
A NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
A IEC 61223-3-5 2004 Edition 1.0, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)]
A NEMA NU 2-2018, Performance Measurements of Positron Emission Tomographs

Software

NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine A (DICOM)
A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Biocompatibility

A ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
A ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices - Part

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Image /page/7/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" shape, which is also in a bold, sans-serif font. The color of the logo is a dark teal.

10: Tests for irritation and skin sensitization.

Other Standards and Guidance

ISO 14971: 2019, Edition 3.0, Medical Devices - Application of risk management to medical devices
Code of Federal Regulations, Title 21. Part 820 Quality System Regulation A
A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
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

Performance Verification

Engineering bench testing was performed on uMI Panorama with uExcel Focus and uMI Panorama with uKinetics to support substantial equivalence and the product performance claims.

uExcel Focus

The images were compared for:

A Volume relative to no motion correction (△Volume)
A Maximum standardized uptake value relative to no motion correction (ASUVmax)
A Mean standardized uptake value relative to no motion correction (△SUVmean).

The performance evaluation showed that uExcel Focus could reduce respiratory motion effects and improve the accuracy of SUV and lesion volume in comparison with no motion correction.

uKinetics

The images were compared for:

A Bias of area under curve (AUC) of the estimated image-derived input function (IDIF).
A Bias of Ki and intercept in the hot spheres in the IO phantom.

A Coefficient of variation (CoV) of the background region in the IQ phantom.

Bench test showed that uKinetics can provide quantitatively accurate parametric images.

Clinical Image Evaluation

A blind comparison was conducted between uMI Panorama with/without uExcel Focus. Two American board-certified nuclear medicine physicians were invited to evaluate the images independently. Clinical evaluation shows that all images produced by uMI Panorama with uExcel Focus are sufficient for clinical diagnosis and uExcel Focus can reduce attenuation correction artifacts and improve PET-CT alignment.

Summary

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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized icon that appears to be a capital letter 'U' with a horizontal line through the middle.

The features described in this premarket submission are supported with the results of the testing mentioned above, the uMI Panorama 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 similar intended use, performance, safety equivalence, and effectiveness 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

§ 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.