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 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.

AI/ML Overview

The provided FDA 510(k) summary (K183143 for uCT 520, uCT 528) describes a computed tomography X-ray system. This submission does not contain information related to an AI/ML device or its performance criteria. The core of the document focuses on demonstrating substantial equivalence to a predicate CT device (uCT 530, uCT 550) based on hardware specifications, application features (some of which are algorithms like iterative noise reduction and metal artifact reduction, but not "AI" in the contemporary sense of machine learning for diagnostic interpretation), and conformance to various medical device standards.

Therefore, I cannot provide acceptance criteria and study details for an AI/ML device's performance as the input document does not pertain to such a device.

Here's an analysis based on the information provided, reinterpreting the request to align with the type of device discussed:

The document focuses on demonstrating substantial equivalence of the uCT 520/uCT 528 Computed Tomography X-ray System to a predicate device (uCT 530/uCT 550). The "acceptance criteria" discussed are primarily related to general CT system performance specifications and safety standards, rather than the diagnostic performance of an AI/ML algorithm.

Acceptance Criteria and Reported Device Performance (Non-AI/ML CT System)

Criteria Category	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed: uCT 520 / uCT 528)	Remarks
General/Regulatory	Product Code: JAK, Regulation No: 21 CFR 892.1750, Class: II, Intended Use: Same	Same	Same
Specifications - Core	Scan Regime: Continuous Rotation, Scan Modes: Scout, Axial, Helical, Detector Material: Solid-state GOS, Z-plane coverage: 22mm, Size of detector element in Z-plane: 0.55mm, Number of element per row: 864, Number of detector row: 40	Same	Same
Specifications - Multi-slice	Maximum slices generated per rotation: 40 for uCT 530, 80 for uCT 550	80 for uCT 520, 80 for uCT 528	Note 1: With a reconstruction process, 40 slices or 80 slices can be achieved from the 40 rows detector. Provides the smaller slice number in one rotation induces longer scanning time for CT imaging, which does not affect safety and effectiveness. (Though uCT 520 now matches uCT 550 at 80 slices).
Specifications - X-ray Tube	Tube anode storage capacity: 5.3MHU, Maximum cooling rate: 815 kHU/min	Tube anode storage capacity: 2MHU for uCT 520, 3.5MHU for uCT 528; Maximum cooling rate: 336 kHU/min for uCT 520, 395 kHU/min for uCT 528	Note 2 & 3: Lower storage capacity and cooling rate affect continuous scan numbers/throughput but not individual scan safety/effectiveness.
Specifications - Focal Spot	Focal spot size: 0.5x1.0mm, 1.0x1.0mm	0.7x0.8mm, 1.2x1.4mm	Note 4: Different focal spot sizes, but image spatial resolution is considered equivalent substantially.
Specifications - Power	Power: 50kW, mA Range: 10-420mA, kV Settings: 70, 80, 100, 120, 140	Power: 42kW, mA Range: 10-350mA, kV Settings: 70, 80, 100, 120, 140	Note 5 & 6: Lower power and mA output might induce higher possibility of photon starvation for high BMI objects, but safety was evaluated by testing. kV settings are the same.
Specifications - Rotation	Rotation speed: Up to 0.5 sec per 360° rotation	Up to 0.75 sec per 360° rotation	Note 7: Slower rotation speed induces longer scan time, but does not affect safety and effectiveness.
Specifications - Table/Gantry	Scannable range: 1700 mm, Horizontal motion range: 2180 mm, Vertical motion range: 480-950 mm	Scannable range: 1600 mm, Horizontal motion range: 1930 mm, Vertical motion range: 600-950 mm from the floor (Vertical speed: Up to 20 mm/sec vs 40 mm/sec predicate)	Note 8, 9, 10, 11: Differences in ranges and speeds affecting scan coverage, room size, and throughput, but not safety and effectiveness.
Image Performance	Image Spatial Resolution: High mode: >20 lp/cm @ MTF 0%, 16.5±1.7 lp/cm @ MTF10%, 11.5±1.2 lp/cm @ MTF50%	High mode: 19 lp/cm @ MTF 0%, 15.6±1.6 lp/cm @ MTF10%, 11.3±1.2 lp/cm @ MTF50%	Note 12: Proposed device has slightly lower spatial resolution (e.g., 0.32mm vs 0.30mm detectability @ MTF10%), but considered equivalent in visual assessment and does not affect safety/effectiveness.
	Image Noise: 3.0±0.5 HU at 120 kV, 5 mm slice thickness, CTDIvol 28.9	3.0±0.5 HU at 120 kV, 5.5 mm slice thickness, CTDIvol 24.32 mGy (uCT 520) & 25.95 mGy (uCT 528)	Note 13: Image noise level considered substantially equivalent, even with slightly different CTDIvol values.
Safety & Compliance	Electrical Safety: Comply with ES60601-1, EMC: Comply with IEC60601-1-2	Comply with ES60601-1, Comply with IEC60601-1-2, conformity to other relevant medical electrical standards (e.g., IEC 60601-2-44, NEMA XR 25, 28, 29). Biocompatibility: Patient Contact Materials tested for cytotoxicity, irritation and sensitization (ISO 10993-5, 10). Software: Conformance to IEC 62304, NEMA PS 3.1-3.20 (DICOM), FDA guidances on software and cybersecurity.	Demonstrated conformance to listed standards for electrical safety, EMC, radiation protection, biocompatibility, and software development, including cybersecurity. This is the primary "proof" of meeting safety acceptance criteria.

As this document describes a conventional CT scanner and not an AI/ML diagnostic device, the following points address what would be expected for an AI/ML device but are not present in the provided text.

Information NOT Available for an AI/ML Device:

Sample sized used for the test set and the data provenance: Not applicable to a non-AI CT system's performance, which is validated through phantom and physical measurements, and clinical image evaluation for quality.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For fundamental CT image quality, ground truth is often established by physical phantoms and expert human evaluation of image quality rather than diagnostic findings. The document mentions "Clinical Evaluation for sample clinical images evaluation," but provides no details on expert numbers or qualifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the device type and testing described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted reading device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's "performance" is its ability to acquire and reconstruct images, not interpret them diagnostically without human input.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the image quality itself, physical phantom measurements and subjective assessment of clinical images are used. For an AI/ML device, this would refer to the diagnostic truth.
The sample size for the training set: Not applicable, as this is not an AI/ML device in the context of diagnostic interpretation.
How the ground truth for the training set was established: Not applicable.

In summary, the provided submission (K183143) is for a conventional CT scanner, and its "acceptance criteria" are demonstrated through engineering specifications, conformance to international standards for safety and performance (e.g., NEMA, IEC), and internal non-clinical performance tests (dosimetry, image performance, AEC, MAC performance evaluation). No AI/ML components requiring diagnostic performance studies, expert ground truth, or human-in-the-loop evaluations are described.

Summary

{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

☑ 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."

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: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com

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:

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.Model	Tube anode storage capacity(MHU)
	uCT 520
uCT 528	3.5

Indications for Use 6.

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 DeviceuCT 520, uCT 528	Predicate DeviceuCT 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 ComputedTomography X-ray SystemuCT520/uCT528 is a computedtomography X-ray systemintended to produce cross-sectional images of the bodyby computer reconstruction ofX-ray transmission data takenat different angles and planesand indicated for the wholebody (including head, neck,vascular).	The uCT ComputedTomography X-ray SystemuCT530/uCT550 is acomputed tomography X-raysystem intended to producecross-sectional images of thebody by computerreconstruction of X-raytransmission data taken atdifferent angles and planesand indicated for the wholebody (including head, neck,vascular).	Same
Specifications
Scan Regime	Continuous Rotation	Continuous Rotation	Same
Scan Modes	ScoutAxial ScanHelical Scan	ScoutAxial ScanHelical Scan	Same
DetectorMaterial	Solid-state GOS	Solid-state GOS	Same
Z-planecoverage	22mm	22mm	Same
Size of detectorelement in Z-plane	0.55mm	0.55mm	Same
Number ofelement per row	864	864	Same
Number ofdetector 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 5203.5MHU for uCT 528	5.3MHU	Note No.2
Maximum cooling rate	336 kHU/min for uCT 520395 kHU/min for uCT 528	815 kHU/min	Note No.3
Focal spot size	0.7x0.8mm1.2x1.4mm	0.5x1.0mm1.0x1.0mm	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:19 lp/cm @ MTF 0%15.6±1.6 lp/cm @ MTF10%11.3±1.2 lp/cm @ MTF50%	High mode:>20 lp/cm @ MTF 0%16.5±1.7 lp/cm @ MTF10%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 mmslice thickness, CTDIvol 25.95mGy for uCT 528
CT NumberDisplay Range	-1024 ~+8191 HU	Same
Scan Field ofView	Up to 500 mm	Same
ReconstructionField of View	40mm-500mm40mm-600mm with extend FOV	Same
Image Matrix	Up to 1024 x 1024	Same
Reconstructedslice thickness	0.55mm,1.1mm,2.2mm,5.5mm,11mm (axial)0.55-10mm(helical)	Same
Pitch	0.1~2.0	Same
Maximumcontinuousexposure time	Up to 100seconds	Same
Safety
Electrical Safety	Comply with ES60601-1	Same
EMC	Comply with IEC60601-1-2	Same
Biocompatibility	Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10).	Same
Clinical	Sample clinical image for both proposed and predicate devices areprovided in Section 37 Clinical Evaluation. Electronic file for each imageare provide in MISC Folder.
Justification	Justification
Note ID	With a reconstruction process, 40 slices or 80 slices can be achieved fromthe 40 rows detector. Provides the smaller slice number in one rotationinduces longer scanning time for CT imaging, which does not affectsafety and effectiveness.
Note 1	Tube anode storage capacity is a kind of measurement about themaximum throughput of CT scanner. When an independent scan isimplemented, the tube is heated and if the time interval between twoindependent scans is long enough, the heat can be dissipated timely butfor short scan time interval, the heat which has not been dissipated timelyshould be stored within tube device and thus for the continuous scans (forshort scan time intervals), higher storage capacity means that morecontinuous scan numbers can be supported. However, tube anode storagecapacity 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 maximumthroughput of CT scanner. For the continuous scans, higher maximumcooling rate means that the tube heat can be dissipated faster and thusshorter scan time interval and more continuous scan numbers can besupported. However, it has no effect on each independent scan.
Note 4	Focus spot size has effect on image spatial resolution and smaller size ishelpful for resolution improvement. However, the image spatial resolutionbetween the two kinds of devices is equivalent substantially.
Note 5	Provides the smaller power output that induces lower ability of x-raypenetration when scanning the object with high BMI with higherpossibility of photon starvation, and the safety has been evaluated by therelated testing and verification.
Note 6	Provides the smaller mA output that induces lower ability of x-raypenetration when scanning the object with high BMI with higherpossibility of photon starvation, and the safety has been evaluated by therelated testing and verification.
Note 7	Provides slower rotation speed that induces longer scan time forexamination which does not affect safety and effectiveness.
Note 8	A typical CT scan is to scan a specific length of the anatomical structure.1600mm scannable range capability of the proposed device have satisfiedmost of size of human anatomical structure. The scannable rangedifference does not affect safety and effectiveness.
Note 9	The horizontal motion range of the device affects the size of the scanningroom, in other words, it will affect site planning. The difference ofhorizontal motion range does not affect safety and effectiveness.
Note 10	Vertical motion range is decided by device gantry and couch designwhich does not affect safety and effectiveness.
Note 11	The Vertical speed of proposed device is lower than the predicateddevice, that only affect expected scanner scan throughput.The vertical difference does not affect safety and effectiveness.
Note 12	Three values of resolution performance are compared, the 0% response ofthe MTF, 10% response of the MTF, and the 50% response. For someresolution studies, the 10% MTF has more value in relating the numericalperformance to visual assessment of resolution. The detectability of thespatial resolution of the proposed device is 0.32mm (15.6 lp/cm @MTF10%). The detectability of the spatial resolution of the predicatedevice is 0.30mm (16.5 lp/cm @ MTF 10%). The size of 0.32mm isequivalent to that of 0.30mm in visual assessment of resolution, whichdoes not affect safety and effectiveness.
Note 13	With 120 kV and 5.5mm slice thickness, the image noise for typical headis 3HU on CTDIvol 24.32 mGy & on CTDIvol 25.95 mGy. The imagenoise level is equivalent substantially considering the proposed device hasmeasured its noise based on the smaller CTDIvol than the PredicateDevice.

{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 application features.

Table 2 below provides a comparison of the application features of the proposed device in comparison to the predicate device.

Key Items	Proposed DeviceuCT 520, uCT 528	Predicate DeviceuCT 530, uCT 550	Remark
Scan Mode	● Scout Scan● Axial Scan● Helical Scan● Contrast enhanced scan■ Manual scan■ Timed scan■ Bolus Tracking■ TIBT● Stationary perfusion scan	● Scout Scan● Axial Scan● Helical Scan● Contrast enhanced scan■ Manual scan■ Timed scan■ Bolus Tracking■ TIBT● Stationary perfusion scan	Same
	Iterative noisereduction	KARL 3DAdaptive Filter	KARL 3DAdaptive Filter
	Metal artifactreduction	MAC	MAC
	Automaticexposure control(AEC)	uDose	uDose
	Fast workflow	uECO Energy-SavingModuleEasy-Logic IntelligentPrediction Platform	uECO Energy-SavingModuleEasy-Logic IntelligentPrediction Platform

Table 2 Comparison of Application Features

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 uCT 520/uCT 528 during the product development.

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

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uCT 520/528 in accordance with the following standards:

{10}------------------------------------------------

Image /page/10/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 words is a stylized "U" symbol, which is made up of two vertical lines and a horizontal line in the middle. The logo is simple and modern, and the use of bold font and the stylized "U" symbol make it easily recognizable.

ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-2-44 Edition 3.0 2009, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of Xray Equipment For Computed Tomography
A IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
A IEC 60825-1 Edition 3.0 2014, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements

Product Particular Standards

A NEMA XR 25-2010, Computed Tomography Dose Check
A NEMA XR 28-2013, Supplemental Requirements For User Information And System Function Related To Dose In CT
NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
A IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-ray Equipment
A IEC 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment

Performance Verification

Clinical Evaluation for sample clinical images evaluation;
A AEC Test Report for AEC performance study.
A MAC Performance Evaluation Report

Software

NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM)
A IEC 62304: Medical Device Software - software life cycle process
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 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

Other Standards and Guidances

Page 8 of 9

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in bold. The logo is simple and modern, and the colors are muted.

ISO 14971: Medical Devices - Application of risk management to medical devices
Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
A Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

Software Verification and Validation

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

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

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

Clinical Testing

No Clinical Study is included in this submission.

Summarv

The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 520/uCT 528 was found to have a safety and effectiveness profile that is similar to the predicate device.

9. Conclusions

Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.