K Number

Device Name

uMI Panorama

Manufacturer

Shanghai United Imaging Healthcare Co., Ltd.

Date Cleared

2023-03-10

(130 days)

Product Code

KPS JAK

Regulation Number

892.1200

Intended Use

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 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, restaging, treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology 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. * 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.

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 PET system features the following specification and technologies. - 760mm patient bore size. - Scalable LYSO detector configurations (96-ring and 120-ring) to have scalable Axial Field of Views (AFOV) of 280 and 350mm respectively, with corresponding imaging performances. - 318 kg maximum table load capacity allows flexible positioning and access for all patients. - uExcel Iterative (also named HYPER Iterative, has been cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function. - uExcel DPR (also named HYPER AiR, has been cleared in K210001), involves pre-trained neural networks in the iteration reconstruction process to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images. - uExcel Focus (also named HYPER Focus, has been cleared in K210418), a respiratory motion correction feature can compromise respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume. The CT system is UIH's 40mm detector uCT ATLAS Astound, which can also be used for standalone, diagnostic CT imaging. The control and reconstruction system contains image acquisition and reconstruction. image display and post processing, data and patient management. CT dose display, networking, filming, etc.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K172143

Reference Devices

K193241, K210001, K210418

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions "uExcel DPR (also named HYPER AiR, has been cleared in K210001), involves pre-trained neural networks in the iteration reconstruction process". Neural networks are a form of machine learning.

Therapeutic

No
The device is described as a "diagnostic imaging system" intended to "assist healthcare providers in assessing metabolic and physiological functions" and "assist in the detection, localization, diagnosis, staging, restaging, treatment response evaluation". Its functions are related to providing images and information for diagnosis and evaluation, not for treating diseases or conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The uMI Panorama is a diagnostic imaging system..." and further elaborates on its use "to assist in the detection, localization, diagnosis, staging, restaging, treatment response evaluation for diseases, inflammation, infection and disorders."

SaMD (Software as a Medical Device)

The device description explicitly states that the system includes hardware components such as a PET system, CT system, patient table, power distribution unit, and vital signal module, in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The uMI Panorama is an in vivo diagnostic imaging system. It uses PET and CT technologies to acquire images of the inside of a patient's body. The diagnostic information is derived from the images themselves, not from analyzing samples taken from the patient.
Intended Use: The intended use clearly states that the system assists in the detection, localization, diagnosis, staging, restaging, and treatment response evaluation for diseases, inflammation, infection, and disorders within the patient body.

While the system provides diagnostic information, it does so by imaging the patient directly, which is the hallmark of an in vivo diagnostic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter states "Control Plan Authorized (PCCP) and relevant text Not Found", which does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Overview

Intended Use / Indications for Use

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology 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. * 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.

Product codes (comma separated list FDA assigned to the subject device)

KPS, JAK

Device Description

The PET system features the following specification and technologies.

760mm patient bore size.
. Scalable LYSO detector configurations (96-ring and 120-ring) to have scalable Axial Field of Views (AFOV) of 280 and 350mm respectively, with corresponding imaging performances.
. 318 kg maximum table load capacity allows flexible positioning and access for all patients.
. uExcel Iterative (also named HYPER Iterative, has been cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.
. uExcel DPR (also named HYPER AiR, has been cleared in K210001), involves pre-trained neural networks in the iteration reconstruction process to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.
. uExcel Focus (also named HYPER Focus, has been cleared in K210418), a respiratory motion correction feature can compromise respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.
The CT system is UIH's 40mm detector uCT ATLAS Astound, which can also be used for standalone, diagnostic CT imaging.

The control and reconstruction system contains image acquisition and reconstruction. image display and post processing, data and patient management. CT dose display, networking, filming, etc.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

PET, CT

Anatomical Site

Not limited to oncology and neurology. The CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified healthcare professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K172143

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K193241, K210001, K210418

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 10, 2023

Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA

Re: K223325/S001

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: February 17, 2023 Received: February 17, 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 (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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

D. Rayfield

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 Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K223325

Device Name uMI Panorama

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.

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."

Image /page/3/Picture/1 description: The image contains 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 text is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.

510 (K) SUMMARY

K223325

1. Date of Preparation October 29, 2022

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

4. Identification of Primary/Reference Device(s)

Predicate Device

510(k) Number: K172143 Device Name: uMI 780 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

Reference Device#1

510(k) Number: K193241 Device Name: uMI 550

Image /page/4/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" symbol, which is made up of two vertical lines and a horizontal line, forming a shape that resembles a shield or emblem. The color of the logo is a dark teal or blue-gray.

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

Reference Device#2

510(k) Number: K210001 Device Name: HYPER AiR Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS Review Panel: Radiology

Reference Device#3

510(k) Number: K210418 Device Name: HYPER Focus Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS Review Panel: Radiology

5. Device Description:

The PET system features the following specification and technologies.

760mm patient bore size.
. Scalable LYSO detector configurations (96-ring and 120-ring) to have scalable Axial Field of Views (AFOV) of 280 and 350mm respectively, with corresponding imaging performances.
. 318 kg maximum table load capacity allows flexible positioning and access for all patients.
. uExcel Iterative (also named HYPER Iterative, has been cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.
. uExcel DPR (also named HYPER AiR, has been cleared in K210001), involves pre-trained neural networks in the iteration reconstruction process to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.

Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, uppercase letters, stacked on two lines. To the right of the text is a stylized, dark teal-colored icon that resembles the letter 'U' with a horizontal line through the middle, creating a negative space 'I' shape.

. uExcel Focus (also named HYPER Focus, has been cleared in K210418), a respiratory motion correction feature can compromise respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.
The CT system is UIH's 40mm detector uCT ATLAS Astound, which can also be used for standalone, diagnostic CT imaging.

The control and reconstruction system contains image acquisition and reconstruction. image display and post processing, data and patient management. CT dose display, networking, filming, etc.

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.

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 similar indications for use as the predicate device uMI 780. A comparison between the technological characteristics of proposed and predicate devices is provided as below.

Image /page/6/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 letter "U" that is also in a bold font. The color of the logo is a dark gray.

| ITEM | Proposed Device
uMI Panorama | Predicate Device
uMI 780 (K172143) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Patient bore size | 760mm | 700mm |
| PET System | Scintillator material: LYSO
Number of detector rings:
• 96 (uMI Panorama 28)
• 120 (uMI Panorama 35)
Axial FOV:
• 280mm (uMI Panorama 28)
• 350mm (uMI Panorama 35) | Scintillator material: LYSO
Number of detector rings: 112
Axial FOV: 300mm |
| CT System | uCT ATLAS Astound (K223028) | uCT 780 (K172135) |
| Maximum table load | 318kg | 250kg |
| Post-processing software | | |
| uExcel Iterative | Yes | No |
| uExcel DPR | Yes | No |
| uExcel Focus | 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)

A 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
A IEC60601-1-2:2014+A1:2020, Medical electrical equipment - Part 1-2: General 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

Image /page/7/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized symbol that resembles a shield or a stylized letter U with a vertical line running through the center and a horizontal line across the top, creating a cross-like shape within the shield.

performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.

IEC 60601-2-44:2009+A1:2012+A2:2016 Medical electrical equipment Part A 2-44: Particular requirements for the basic safety and essential performance of X-ray 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.
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
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

A NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine (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 10: Tests for irritation and skin sensitization.

Other Standards and Guidance

A ISO 14971: 2019, Edition 3.0, Medical Devices - Application of risk management to medical devices
A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
A Provision for Alternate Measure of the Computed Tomography Dose Index

Image /page/8/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, dark gray icon that resembles a shield or a rounded "U" shape with a vertical line running through the center. The overall design is clean and modern.

(CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

Summary

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.