uCT 760/780 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 indicated for the whole body (including head, neck, cardiac and vascular).

uCT 760/780 is intended to 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.

uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

Device Description

The uCT Computed Tomography X-ray system is intended to produce crosssectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.

This proposed device includes two models: uCT 760 and uCT 780. The differences between the two models are as follows:

Spec.Model	HV Power	Rotation speed	Minimumslice thickness	Maximumslices generatedper rotation
uCT 760	80kW	Up to 0.35 sec per360° rotation	0.625mm	128
uCT 780	100kW	Up to 0.3 sec per360° rotation	0.5mm	160

The uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.

The modification performed on the uCT 760 & 780 in this submission is mainly due to the following new features:

Low Dose CT Lung Cancer Screening Protocol .
. uAI Vision
. Auto ALARA kVp
Organ-Based Auto ALARA mA
CT-Guided Intervention
Injector Linkage
. Dual Energy Analysis

CT-Guided Intervention is a medical tool for assisting a minimally invasive procedure. CT-Guided Intervention in uCT 760/780 is to provide CT-imaging guidance for interventional procedures. During the CT-Guided Intervention procedure, CT images can help the user guide the needle entry path before operating a minimally invasive procedure and display the placement of the needle during a minimally invasive procedure based on the four scan modes: Single Axial, Continuous, Fluoro and Single helical. In this case, cells or tissue can be taken for biopsy, or minimally invasive surgeries such as drainage and ablation can be performed.

AI/ML Overview

The provided text describes the 510(k) submission for the Shanghai United Imaging Healthcare Co., Ltd.'s uCT 760/780 computed tomography x-ray systems with uWS-CT-Dual Energy Analysis. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing of dosimetry and image performance.

However, the document does not contain specific details regarding:

Acceptance criteria values for device performance (e.g., specific thresholds for accuracy, sensitivity, specificity, or image quality metrics).
A study proving the device meets the acceptance criteria (other than general statements about non-clinical testing).
Sample sizes used for a test set (only mentions overall non-clinical testing).
Data provenance (country of origin, retrospective/prospective).
Number of experts and their qualifications.
Adjudication method.
Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or its effect size.
If standalone (algorithm only) performance was evaluated.
The type of ground truth used (explicitly).
Sample size for the training set.
How ground truth for the training set was established.

The document primarily focuses on:

Indications for Use.
Comparison of technological characteristics to predicate devices.
Conformity to various electrical safety, EMC, biocompatibility, and software standards.

Therefore, based only on the provided text, I cannot fulfill most of the request's specific points. The text indicates that non-clinical testing, including dosimetry and image performance tests, were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. However, it does not provide the details of these tests as requested.

If this were a submission for a software-as-a-medical-device (SaMD) or an AI/ML device, such details would typically be required and present. Given this is a CT scanner with an added "Dual Energy Analysis" software package and "uAI Vision" (which is not detailed), the submission focuses more on the hardware's safety and performance equivalence, and general conformance to standards for the software components rather than a detailed clinical validation study of AI performance.

Therefore, as per the instructions, I will explain why I cannot fulfill the request specifically due to the lack of information in the provided document.

Explanation of Missing Information:

The provided 510(k) summary for the uCT 760/780 with uWS-CT-Dual Energy Analysis does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets these criteria in the manner requested. Specifically:

Table of acceptance criteria and reported device performance: The document states that "non-clinical testing including dosimetry and image performance tests were conducted... to verify that the proposed device met all design specifications," but it does not list the specific acceptance criteria (e.g., quantitative metrics for image quality, accuracy of dual-energy analysis outputs) or the reported numerical performance results against these criteria.
Sample size for the test set and data provenance: No information is provided regarding the sample size of any test set used or the provenance (country of origin, retrospective/prospective nature) of the data. The testing mentioned is "non-clinical," implying laboratory or phantom-based tests rather than clinical study data.
Number and qualifications of experts for ground truth: Since no specific clinical performance or AI diagnostic study is detailed, there is no mention of experts, their number, or qualifications for establishing ground truth.
Adjudication method: Not applicable/not mentioned, as no multi-reader or diagnostic performance study is described.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe an MRMC study or any human-in-the-loop performance evaluation. The "uAI Vision" feature is mentioned but without any performance data or clinical study details.
Standalone (algorithm only) performance: While the "uWS-CT-Dual Energy Analysis" and "uAI Vision" are software features, the document does not present a standalone performance evaluation of these algorithms with specific metrics (e.g., accuracy, sensitivity, specificity) against a defined ground truth.
Type of ground truth used: No specific type of ground truth (e.g., pathology, expert consensus) is mentioned, as no clinical performance study is detailed. The "ground truth" for the non-clinical tests would likely be derived from physical measurements or simulations rather than clinical outcomes.
Sample size for the training set: The document does not discuss the training of any AI/ML models or the size of a training dataset.
How ground truth for the training set was established: Not applicable, as AI training details are not provided.

In summary, the provided document focuses on demonstrating substantial equivalence to existing predicate CT devices through conformity to general safety and performance standards for CT systems and basic non-clinical testing, rather than detailed clinical validation or AI performance studies which would typically include the requested information.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

August 1, 2023

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

Re: K230162

Trade/Device Name: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: July 7, 2023 Received: July 10, 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

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Page 2

Enclosure

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Indications for Use

510(k) Number (if known) K230162

Device Name

uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis

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)	X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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.

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Image /page/3/Picture/1 description: The image shows 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 words is a stylized "U" shape, with a horizontal line running through the middle of the U. The logo is a dark gray color.

510 (K) SUMMARY K230162

1. Date of Preparation July 31, 2023

2. Sponsor Identification

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

Identification of Proposed Device 3.

Trade Name	uCT 760 with uWS-CT-DualEnergy Analysis	uCT 780 with uWS-CT-DualEnergy Analysis
Common Name	Computed Tomography X-ray System
Model(s)	uCT 760	uCT 780

Regulatory Information

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

Identification of Predicate Device(s) 4.

Primary Predicate Device

510(k) Number: K172135 Device Name: uCT 760, uCT 780 Regulation Name: Computed Tomography X-ray System

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Image /page/4/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 "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.

Regulatory Class: II Product Code: JAK Review Panel: Radiology

Secondary Predicate Device 1

510(k) Number: K203448 Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

Secondary Predicate Device 2

510(k) Number: K211373

Device Name: SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite SOMATOM X.ceed, Scan&GO Software Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

5. Device Description:

This proposed device includes two models: uCT 760 and uCT 780. The differences between the two models are as follows:

Spec.Model	HV Power	Rotation speed	Minimumslice thickness	Maximumslices generatedper rotation
uCT 760	80kW	Up to 0.35 sec per360° rotation	0.625mm	128
uCT 780	100kW	Up to 0.3 sec per360° rotation	0.5mm	160

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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" symbol, which is dark gray and has a white horizontal line through the middle. The overall design is clean and modern.

The modification performed on the uCT 760 & 780 in this submission is mainly due to the following new features:

Low Dose CT Lung Cancer Screening Protocol .
. uAI Vision
. Auto ALARA kVp
Organ-Based Auto ALARA mA
CT-Guided Intervention
Injector Linkage
. Dual Energy Analysis

Comparison details are shown in Section 7.

Indications for Use 6.

uCT 760/780 is a computed tomography x-ray system intended to produce crosssectional 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, cardiac and vascular).

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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 symbol that resembles a shield or a rounded square with a vertical line running down the center and a horizontal line across the top, forming a "T" shape within the shield.

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.

Comparison of Technological Characteristics with the Predicate Device 7. The indications for use for the proposed device is same as that for the primary predicate device (K172135), except for the addition of the dual-energy functionality and the low dose CT lung cancer screening, which are same as in the indications for use for the secondary predicate device 1 (K203448).
A comparison between the technological characteristics of proposed and predicate devices is provided as below.

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ITEM	Proposed Device	Predicate DeviceuCT 760, uCT 780(K172135)	Secondary Predicate Device 1uCT ATLAS with uWS-CT-Dual Energy Analysis(K203448)	Secondary Predicate Device 2SOMATOM go.Now, SOMATOM go.Up,SOMATOM go.All, SOMATOM go.Top,SOMATOM go.Sim, SOMATOM go.OpenPro, SOMATOM X.cite SOMATOMX.ceed, Scan&GO Software (K211373)	DiscussionofDifferences
Specifications
Gantry	Rotation speed: up to0.35s/rotation for uCT760; 0.3s/rotation foruCT 78070cm bore	Rotation speed up to0.35s/rotation for uCT760; 0.3s/rotation foruCT 78070cm bore	--	--	Same
Detector	40mm DetectorMaterial: Solid-stateGOS80 rows,936 channels/rowSize of detectorelement in Z-plane:0.5mm	40mm DetectorMaterial: Solid-stateGOS80 rows,936 channels/rowSize of detectorelement in Z-plane:0.5mm	--	--	Same
X-ray Tube	70, 80, 100, 120, 140kVmA range: 10mA-667mA for uCT 760;10mA-667mA, 10mA-833mA(option) foruCT 780Anode heat capacity:7.5MHU	70, 80, 100, 120, 140kVmA range: 10mA-667mA for uCT 760;10mA-667mA, 10mA-833mA(option) foruCT 780Anode heat capacity:7.5MHU	--	--	Same
	Maximum anode heatdissipation:1386kHU/minFocal spot size:$0.7mm \times 0.7mm$$1.0mm \times 1.0mm$	Maximum anode heatdissipation:1386kHU/minFocal spot size:$0.7mm \times 0.7mm$$1.0mm \times 1.0mm$
High Voltage Generator	80kW for uCT 760;80kW, 100kW(option)for uCT 78070, 80, 100, 120, 140kV	80kW for uCT 760;80kW, 100kW(option)for uCT 78070, 80, 100, 120, 140kV	--	--	Same
Patient Table	Max load capacity205kg(StandardConfiguration);318kg(HighConfiguration)	Max load capacity205kg	--	--	Note 1
Maximum Slices	128 for uCT 760	128 for uCT 760	--	--	Same
Generated per Rotation	160 for uCT 780	160 for uCT 780
Reconstruction Field ofView	40-500mm40-600mm withextended FOV	40-500mm40-600mm withextended FOV	--	--	Same
Functions
KARL 3D	Yes	Yes	--	--	Same
Metal ArtifactCorrection (MAC)	Yes	Yes	--	--	Same
ReconstructionField of View	40mm-500mm40mm-600mm withextend FOV	40mm-500mm40mm-600mm withextend FOV	--	--	Same
Auto ALARA mA	Yes	Yes	--	--	Same
CardioXphase	Yes	--	Yes	--	Same

Deep Recon (DELTA)	Yes	Yes	--	--	Same
Low Dose CT LungCancer ScreeningProtocol	Yes	--	Yes	--	Same
uAI Vision-EasyPositioning-EasyISO	Yes	--	Yes	--	Same
Auto ALARA kVp	Yes	--	Yes	--	Same
Organ-Based AutoALARA mA	Yes	--	Yes	--	Same
EasyRange	Yes	--	Yes	--	Same
Injector Linkage	Yes	--	Yes	--	Same
Remote Assistance	Yes	--	Yes	--	Same
Shuttle Perfusion	Yes	--	Yes	--	Same
Real Time 3D	Yes	--	Yes	--	Same
Online MPR	Yes	--	Yes	--	Same
CT-guided Intervention
CT-guided Intervention	Yes	--	--	Yes	FunctionalEquivalent
Hardware (added due to the CT-Guided Intervention)
Scanning RoomMonitor	Yes	--	--	Yes	FunctionalEquivalent
Exposure Foot Pedal	Yes	--	--	Yes	FunctionalEquivalent
Hand Cart	Yes	--	--	Yes	FunctionalEquivalent
Suspension Gear	Yes	--	--	Yes	FunctionalEquivalent
Couch Side Controller	Yes	--	--	Yes	FunctionalEquivalent
Scan mode (added due to the CT-Guided Intervention)
Single Axial Mode	Yes	--	--	i-Sequence Functional Equivalent
Single Helical Mode	Yes	--	--	i-Spiral Functional Equivalent
Fluoro Mode	Yes	--	--	i-Fluoro Functional Equivalent
Continuous Mode	Yes	--	--	-- Note 2
2D & 3D Path Planning	Yes	--	--	Yes Functional Equivalent
3D Image Guidance	Yes	--	--	Yes Functional Equivalent
Dual Energy
Dual Energy Scan	Yes	--	Yes	-- Same
Dual Energy Analysis
Mono Energetic Image	Yes	--	Yes	-- Same
Mixed Enhanced Image	Yes	--	Yes	-- Same
CNR(Contrast Noise Ratio) Image	Yes	--	Yes	-- Same
Water-Iodine Base Material Pair	Yes	--	Yes	-- Same
Water-Calcium Base Material Pair	Yes	--	Yes	-- Same
Calcium-Iodine Base Material Pair	Yes	--	Yes	-- Same
Uric acid-Calcium Base Material Pair	Yes	--	Yes	-- Same
Image Registration	Yes	--	Yes	-- Same
Effective Atomic Number Images	Yes	--	Yes	-- Same
Component analysis of kidney stones, uric acid stones or non-uric acid stonesComponent analysis of joint gout, uric acid gout or non-uric acid gout
Electron Density Image	Yes	--	Yes	--	Same
Virtual Non Contrast Images	Yes	--	Yes	--	Same

d the Ca Table 1 Ca . na to Dradicato Davias anderri Dradio

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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized icon that appears to be a square with a line through the middle, creating a U-like shape. The logo is simple and modern in design.

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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is written in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold font. The logo is simple and modern in design.

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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the text is a stylized "U" symbol. The symbol is made up of two vertical lines and one horizontal line, creating a shape that resembles a "U" with a line through the middle.

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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold font. The logo is simple and modern in design.

*: The new features that the proposed device compared to predicate device have been highlight in the table.

Note 1: The proposed device is configured with two types of patient table. One is same as the predicate is with higher load capacty than the predicate device. The two tables being a major componed device are conforms to the safety standards such as IEC 60601-1 series and applicable to the performance standards in 21 CFR subchapter J and satisfy with the clinical applications. The difference will not raise new safety and effectiveness concerns.

Note 2: The proposed device adds a scan mode during the inference will not raise new safety and effectiveness concerns.

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Image /page/12/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 words is a stylized "U" shape, which is also in bold. The color of the logo is a dark teal.

Performance Data 8.

● Non-Clinical Testing

Non-clinical testing including dosimetry and image performance tests were conducted for the uCT 760 and uCT 780 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 AAMI ES60601-1:2005+A1:2012+A2:2021, Medical electric for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
A IEC 60601-1-2: 2014, Edition 4.0, 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 performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
A IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
IEC 60825-1: 2014, Edition 3.0, Safety of laser products - Part 1: Equipment classification and requirements.
A IEC 60601-1-6: 2010+A1:2013+A2:2020, Edition 3.2, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
A NEMA XR 25-2019, Computed Tomography Dose Check
A NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT
A NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
A IEC 61223-3-5:2004+COR1:2006, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
Software
A NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine

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Image /page/13/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 "U" shape, which is also in a bold font. The color of the text and the "U" shape is a dark gray.

(DICOM)

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

ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices Part A 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 Guidances

ISO 14971: 2019, Edition 3.0, Medical Devices Application of risk A 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 (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

Summarv

The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 760 and uCT 780 were found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusions 9.

Based on the comparison and analysis above, the proposed device has same intended use, similar performance, safety equivalence, and effectiveness as the predicate devices. The differences above between the proposed device and predicate devices 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 devices.

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.