uCT 520, uCT 528

K183143 · Shangai United Imaging Healthcare Co., Ltd. · JAK · Jan 3, 2019 · Radiology

Device Facts

• Record ID: K183143
• Device Name: uCT 520, uCT 528
• Applicant: Shangai United Imaging Healthcare Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Jan 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The uCT Computed Tomography X-ray System uCT 520/uCT 528 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

Device Story

Multi-slice CT scanner; uses continuously rotating tube-detector system; fan beam principle. Inputs: X-ray transmission data (snapshots) collected at multiple angles during rotation. Processing: Filter back-projection (FBP) algorithm; KARL iterative denoising; MAC metal artifact correction. Outputs: Cross-sectional DICOM images. Used in clinical settings by trained operators (physicians/technicians). Output used by clinicians for diagnostic visualization and clinical decision-making. Benefits: Provides internal organ/tissue imaging for diagnostic assessment.

Clinical Evidence

No clinical study included. Substantial equivalence supported by bench testing, dosimetry, image performance tests, and clinical image evaluation. Conformance to electrical safety (ES 60601-1), EMC (IEC 60601-1-2), and CT-specific standards (NEMA XR 25, 28, 29) demonstrated.

Technological Characteristics

Multi-slice CT; solid-state GOS detectors; 40 rows; 0.55mm minimum slice thickness; 700mm aperture; ±30° gantry tilt. Power: 42kW. Tube anode storage: 2MHU (uCT 520) / 3.5MHU (uCT 528). Connectivity: DICOM. Software: Moderate level of concern. Biocompatibility: ISO 10993-5/10 compliant.

Indications for Use

Indicated for whole body (head, neck, vascular) CT imaging for patients requiring cross-sectional diagnostic images.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• uCT Computed Tomography X-Ray System (K181414)

Submission Summary (Full Text)

{0}------------------------------------------------

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

January 3, 2019

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

Re: K183143

Trade/Device Name: uCT 520, uCT 528 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 14, 2018 Received: November 15, 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.

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

{1}------------------------------------------------

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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Hole 2. Nils

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K183143

Device Name

uCT 520, uCT 528

Indications for Use (Describe)

The uCT Computed Tomography X-ray System uCT 520/uCT 528 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

| <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|

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

[e-mail]

"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."

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/2 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 "U" shape, which is also in a bold, sans-serif font. The color of the logo is a dark teal.

# 510 (k) SUMMARY

### 1. Date of Preparation November 10, 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: [phone]-6776 Fax: [phone] Email: [e-mail]

### 3. Identification of Proposed Device

Trade Name: uCT 520, uCT 528 Common Name: Computed Tomography X-ray System Model(s): uCT 520, uCT 528

Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

### 4. Identification of Predicate Device(s)

## Predicate Device

510(k) Number: K181414 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 530, uCT 550

Regulatory Information

Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

{4}------------------------------------------------

Image /page/4/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 formed by two vertical lines connected by a horizontal line in the middle. The logo is simple and modern, with a focus on the company name and a clean design.

#### 5. Device Description:

The uCT 520/uCT 528 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format, which can be used by post-processing applications.

The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Software. The system software is a program used for patient management, data management, Xray scan control, image reconstruction, and image archive.

A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a crosssectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.

There are two key features of data processing for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.

This proposed device includes two models: uCT 520, uCT 528.The differences between the two models are as follows:

| Spec.<br>Model | Tube anode storage capacity<br>(MHU) |
|----------------|--------------------------------------|
| | uCT 520 |
| uCT 528 | 3.5 |

#### Indications for Use 6.

The uCT Computed Tomography X-ray System uCT 520/uCT 528 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

### 7. Comparison of Technological Characteristics with the Predicate Devices

{5}------------------------------------------------

Image /page/5/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.

The uCT 520/uCT 528 Computed Tomography X-ray system has the same indications for use as the predicate device uCT 530/uCT 550. 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<br>uCT 520, uCT 528 | Predicate Device<br>uCT 530, uCT 550 | Remark |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | General | | |
| Product Code | JAK | JAK | Same |
| Regulation No. | 21 CFR 892.1750 | 21 CFR 892.1750 | Same |
| Class | II | II | Same |
| Intended Use | The uCT Computed<br>Tomography X-ray System<br>uCT520/uCT528 is a computed<br>tomography X-ray system<br>intended to produce cross-<br>sectional images of the body<br>by computer reconstruction of<br>X-ray transmission data taken<br>at different angles and planes<br>and indicated for the whole<br>body (including head, neck,<br>vascular). | The uCT Computed<br>Tomography X-ray System<br>uCT530/uCT550 is a<br>computed tomography X-ray<br>system intended to produce<br>cross-sectional images of the<br>body by computer<br>reconstruction of X-ray<br>transmission data taken at<br>different angles and planes<br>and indicated for the whole<br>body (including head, neck,<br>vascular). | Same |
| Specifications | | | |
| Scan Regime | Continuous Rotation | Continuous Rotation | Same |
| Scan Modes | Scout<br>Axial Scan<br>Helical Scan | Scout<br>Axial Scan<br>Helical Scan | Same |
| Detector<br>Material | Solid-state GOS | Solid-state GOS | Same |
| Z-plane<br>coverage | 22mm | 22mm | Same |
| Size of detector<br>element in Z-<br>plane | 0.55mm | 0.55mm | Same |
| Number of<br>element per row | 864 | 864 | Same |
| Number of<br>detector row | 40 | 40 | Same |
| Maximum slices | 80 for uCT 520 | 40 for uCT 530 | Note |
| generated per | 80 for uCT 528 | 80 for uCT 550 | No.1 |
| rotation (multi-slice capability) | | | |
| Minimum slice thickness | 0.55mm | 0.55mm | Same |
| Maximum sampling rate | Up to 4800 views per 360° | Up to 4800 views per 360° | Same |
| Tube anode storage capacity | 2MHU for uCT 520<br>3.5MHU for uCT 528 | 5.3MHU | Note No.2 |
| Maximum cooling rate | 336 kHU/min for uCT 520<br>395 kHU/min for uCT 528 | 815 kHU/min | Note No.3 |
| Focal spot size | 0.7x0.8mm<br>1.2x1.4mm | 0.5x1.0mm<br>1.0x1.0mm | Note No.4 |
| Power | 42kW | 50kW | Note No.5 |
| mA Range | 10-350mA | 10-420mA | Note No.6 |
| kV Settings | 70, 80, 100, 120, 140 | 70, 80, 100, 120, 140 | Same |
| Aperture | 700mm | 700mm | Same |
| Rotation speed | Up to 0.75 sec per 360° rotation | Up to 0.5 sec per 360° rotation | Note No.7 |
| Gantry Tilt | ± 30°with 0.5 increment | ± 30°with 0.5 increment | Same |
| Scannable range | 1600 mm | 1700 mm | Note No.8 |
| Horizontal motion range | 1930 mm | 2180 mm | Note No.9 |
| Table Horizontal Speed | Up to 200mm/sec | Up to 200mm/sec | Same |
| Vertical motion range | 600 mm-950 mm from the floor | 480 mm-950 mm from the floor | Note No.10 |
| Vertical speed | Up to 20 mm/sec | Up to 40 mm/sec | Note No.11 |
| Table Horizontal Position accuracy | ±0.25mm | ±0.25mm | Same |
| Table Maximum table load | 205kg | 205kg | Same |
| Image Spatial Resolution | High mode:<br>19 lp/cm @ MTF 0%<br>15.6±1.6 lp/cm @ MTF10%<br>11.3±1.2 lp/cm @ MTF50% | High mode:<br>>20 lp/cm @ MTF 0%<br>16.5±1.7 lp/cm @ MTF10%<br>11.5±1.2 lp/cm @ MTF50% | Note No.12 |
| Image Noise | 3.0±0.5 HU at 120 kV, 5.5 mm slice thickness, CTDIvol 24.32 | 3.0±0.5 HU at 120 kV, 5 mm slice thickness, CTDIvol 28.9 | Note No.13 |
| 3.0±0.5 HU at 120 kV, 5.5 mm<br>slice thickness, CTDIvol 25.95<br>mGy for uCT 528 | | | |
| CT Number<br>Display Range | -1024 ~+8191 HU | Same | |
| Scan Field of<br>View | Up to 500 mm | Same | |
| Reconstruction<br>Field of View | 40mm-500mm<br>40mm-600mm with extend FOV | Same | |
| Image Matrix | Up to 1024 x 1024 | Same | |
| Reconstructed<br>slice thickness | 0.55mm,1.1mm,2.2mm,5.5mm,11mm (axial)<br>0.55-10mm(helical) | Same | |
| Pitch | 0.1~2.0 | Same | |
| Maximum<br>continuous<br>exposure time | Up to 100seconds | Same | |
| Safety | | | |
| Electrical Safety | Comply with ES60601-1 | Same | |
| EMC | Comply with IEC60601-1-2 | Same | |
| Biocompatibility | Patient Contact Materials were<br>tested and demonstrated no<br>cytotoxicity (ISO 10993-5), no<br>evidence for irritation and<br>sensitization (ISO 10993-10). | Same | |
| Clinical | Sample clinical image for both proposed and predicate devices are<br>provided in Section 37 Clinical Evaluation. Electronic file for each image<br>are provide in MISC Folder. | | |
| Justification | Justification | | |
| Note ID | With a reconstruction process, 40 slices or 80 slices can be achieved from<br>the 40 rows detector. Provides the smaller slice number in one rotation<br>induces longer scanning time for CT imaging, which does not affect<br>safety and effectiveness. | | |
| Note 1 | Tube anode storage capacity is a kind of measurement about the<br>maximum throughput of CT scanner. When an independent scan is<br>implemented, the tube is heated and if the time interval between two<br>independent scans is long enough, the heat can be dissipated timely but<br>for short scan time interval, the heat which has not been dissipated timely<br>should be stored within tube device and thus for the continuous scans (for<br>short scan time intervals), higher storage capacity means that more<br>continuous scan numbers can be supported. However, tube anode storage<br>capacity has no effect on each independent scan | | |
| Note 2 | | | |

Table 1 Comparison of Technological Characteristics

{6}------------------------------------------------

Image /page/6/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" symbol, which is formed by two vertical lines and a horizontal line in the middle, creating a shape that resembles a shield or a stylized "U".

{7}------------------------------------------------

Image /page/7/Picture/0 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 divided into two halves by a vertical line. A horizontal line connects the vertical line to the right side of the "U" shape.

{8}------------------------------------------------

Image /page/8/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" symbol, which is formed by a thick, vertical line with a horizontal line cutting through the middle, creating a negative space in the shape of a "T".

| Note 3 | Maximum cooling rate is a kind of measurement about the maximum<br>throughput of CT scanner. For the continuous scans, higher maximum<br>cooling rate means that the tube heat can be dissipated faster and thus<br>shorter scan time interval and more continuous scan numbers can be<br>supported. However, it has no effect on each independent scan. |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 4 | Focus spot size has effect on image spatial resolution and smaller size is<br>helpful for resolution improvement. However, the image spatial resolution<br>between the two kinds of devices is equivalent substantially. |
| Note 5 | Provides the smaller power output that induces lower ability of x-ray<br>penetration when scanning the object with high BMI with higher<br>possibility of photon starvation, and the safety has been evaluated by the<br>related testing and verification. |
| Note 6 | Provides the smaller mA output that induces lower ability of x-ray<br>penetration when scanning the object with high BMI with higher<br>possibility of photon starvation, and the safety has been evaluated by the<br>related testing and verification. |
| Note 7 | Provides slower rotation speed that induces longer scan time for<br>examination which does not affect safety and effectiveness. |
| Note 8 | A typical CT scan is to scan a specific length of the anatomical structure.<br>1600mm scannable range capability of the proposed device have satisfied<br>most of size of human anatomical structure. The scannable range<br>difference does not affect safety and effectiveness. |
| Note 9 | The horizontal motion range of the device affects the size of the scanning<br>room, in other words, it will affect site planning. The difference of<br>horizontal motion range does not affect safety and effectiveness. |
| Note 10 | Vertical motion range is decided by device gantry and couch design<br>which does not affect safety and effectiveness. |
| Note 11 | The Vertical speed of proposed device is lower than the predicated<br>device, that only affect expected scanner scan throughput.<br>The vertical difference does not affect safety and effectiveness. |
| Note 12 | Three values of resolution performance are compared, the 0% response of<br>the MTF, 10% response of the MTF, and the 50% response. For some<br>resolution studies, the 10% MTF has more value in relating the numerical<br>performance to visual assessment of resolution. The detectability of the<br>spatial resolution of the proposed device is 0.32mm (15.6 lp/cm @<br>MTF10%). The detectability of the spatial resolution of the predicate<br>device is 0.30mm (16.5 lp/cm @ MTF 10%). The size of 0.32mm is<br>equivalent to that of 0.30mm in visual assessment of resolution, which<br>does not affect safety and effectiveness. |
| Note 13 | With 120 kV and 5.5mm slice thickness, the image noise for typical head<br>is 3HU on CTDIvol 24.32 mGy & on CTDIvol 25.95 mGy. The image<br>noise level is equivalent substantially considering the proposed device has<br>measured its noise based on the smaller CTDIvol than the Predicate<br>Device. |

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font, stacked vertically. To the right of the text is a stylized graphic, which appears to be a letter "U" with a horizontal line through the middle, creating a cross-like shape within the "U". The logo is simple and modern in design.

The proposed device and the predicate device are the same in regard to most of app…