uMI 780 PET/CT System

K172143 · Shanghai United Imaging Healthcare Co., Ltd. · KPS · Apr 13, 2018 · Radiology

Device Facts

• Record ID: K172143
• Device Name: uMI 780 PET/CT System
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: KPS · Radiology
• Decision Date: Apr 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

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

Device Story

uMI 780 PET/CT system combines PET and CT modalities for diagnostic imaging. PET component measures quantitative distribution of radiopharmaceuticals; CT component provides anatomical tomographic images and photon attenuation maps. System performs spatial alignment and image registration/fusion to provide anatomical reference for PET findings. Operated by qualified healthcare professionals in clinical settings. Workstation software manages patient data, scan control, image reconstruction, and reading. Output consists of fused PET/CT images used by physicians for disease assessment, staging, and treatment planning. Benefits include improved diagnostic accuracy through combined metabolic and anatomical data.

Clinical Evidence

Bench testing only. No clinical study included. Performance verified via NEMA NU 2:2012 testing and compliance with electrical/radiation safety standards (IEC 60601 series, AAMI ANSI ES60601-1).

Technological Characteristics

Combined PET/CT scanner. PET: Time-of-flight capability, 520ps timing resolution, 300mm axial FOV. CT: 80 detector rows, 40mm Z-plane coverage, 0.5mm min slice thickness, 0.3s rotation speed. Connectivity: DICOM 3.0. Biocompatibility: ISO 10993-5, ISO 10993-10. Electrical/EMC: IEC 60601-1, IEC 60601-1-2. Radiation safety: NEMA XR 25, XR 28, XR 29.

Indications for Use

Indicated for diagnostic imaging to assist in detection, localization, diagnosis, staging, treatment planning, and treatment response evaluation for diseases and disorders, including but not limited to oncology, cardiology, and neurology. Intended for use by qualified healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Biograph mCT and mCT Flow PET/CT Scanners (K151486)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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):

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.

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.

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

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FORM FDA 3881 (8/14)

PSC Publishing Services [phone] FF

### SECTION 77 - 1 of 1

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# SECTION 16

# 510(k) Summary

SECTION 16 - Page 1 of 7

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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 |
| Establishment<br>Registration Number: | Not yet registered |
| Contact Person: | Wang Shumei |
| Position: | QM&RA VP |
| Tel: | [phone]-6776 |
| Fax: | [phone] |
| Email: | [e-mail] |

#### 3. Identification of Proposed Device

| Model(s): | uMI 780 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Trade Name: | uMI 780 |
| Common Name: | Positron Emission Tomography and<br>Computed Tomography System |
| Classification Name: | Emission Computed Tomography System per 21 CFR 892.1200<br>Computed 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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Image /page/5/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" symbol, which is also in a bold, sans-serif font. The logo is simple and modern, and the use of a bold font gives it a strong and confident look.

#### Proposed Device Description 4.

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.

### 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

## SECTION 16 - Page 3 of 7

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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) System<br>Computed 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 a<br>diagnostic imaging system that<br>combines two existing imaging<br>modalities - PET and CT. The<br>quantitative distribution<br>information of PET<br>radiopharmaceuticals within the<br>patient body measured by PET can<br>assist healthcare providers in<br>assessing the metabolic and<br>physiological functions. CT<br>provides diagnostic tomographic<br>anatomical information as well as<br>photon attenuation information for<br>the scanned region. The accurate<br>registration and fusion of PET and<br>CT images provides anatomical<br>reference for the findings in the<br>PET images.<br>This system is intended to be<br>operated by qualified healthcare<br>professionals to assist in the<br>detection, localization, diagnosis,<br>staging, restaging, treatment<br>planning and treatment response<br>evaluation for diseases and<br>disorders in, but not limit to,<br>oncology, cardiology and<br>neurology. | The Siemens Biograph mCT systems<br>are combined X-Ray Computed<br>Tomography (CT) and Positron<br>Emission<br>Tomography (PET) scanners that<br>provide registration and fusion of<br>high resolution physiologic and<br>anatomic information.<br>The CT component produces cross-<br>sectional images of the body by<br>computer reconstruction of X-Ray<br>transmission data from either the<br>same axial plane taken at different<br>angles or spiral planes taken at<br>different angles. The PET subsystem<br>images and measures the distribution<br>of PET radiopharmaceuticals in<br>humans for the purpose of<br>determining various metabolic<br>(molecular) and physiologic<br>functions within the human body and<br>utilizes the CT for fast attenuation<br>correction maps for PET studies and<br>precise anatomical reference for the<br>fused PET and CT images.<br>The system maintains independent<br>functionality of the CT and PET<br>devices, allowing for single modality<br>CT and / or PET diagnostic imaging.<br>These systems are intended to be<br>utilized by appropriately trained<br>health care professionals to aid in<br>detecting, localizing, diagnosing,<br>staging and restaging of lesions,<br>tumors, disease and organ function<br>for the evaluation of diseases and<br>disorders such as, but not limited to,<br>cardiovascular disease, neurological<br>disorders and cancer. The images<br>produced by the system can also be<br>used by the physician to aid in<br>radiotherapy treatment planning and<br>interventional 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 | Topo<br>Axial Scan<br>Helical Scan | Topo<br>Axial Scan<br>Helical 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 | |…