uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver.
The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway.
The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in brain.
The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.
The CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes.
The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk.
The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.

Device Description

uWS-CT is a comprehensive software solution designed to process, review and analyze CT studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.

AI/ML Overview

The provided document, a 510(k) summary for the uWS-CT software, does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets these criteria in the way typically required for AI/ML-driven diagnostics.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (uWS-CT K173001) and several reference devices for its various CT analysis applications. It lists the functions of the new and modified applications (e.g., CT Lung Density Analysis, CT Brain Perfusion, CT Heart, CT Calcium Scoring, CT Dynamic Analysis, CT Bone Structure Analysis, CT Liver Evaluation) and compares them to those of the predicate and reference devices, indicating that their functionalities are "Same."

While the document states that "Performance data were provided in support of the substantial equivalence determination" and lists "Performance Evaluation Report" for various CT applications, it does not provide the specifics of these performance evaluations, such as:

Acceptance Criteria: What specific numerical thresholds (e.g., accuracy, sensitivity, specificity, Dice score for segmentation) were set for each function?
Reported Device Performance: What were the actual measured performance values?
Study Design Details: Sample size, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, or results of MRMC studies.

The document explicitly states:

"No clinical study was required." (Page 16)
Software Verification and Validation was provided, including hazard analysis, SRS, architecture description, environment description, and cyber security documents. However, these are general software development lifecycle activities and not clinical performance studies.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide the detailed study information. The document suggests that the performance verification was focused on demonstrating functional equivalence rather than presenting quantitative performance metrics against pre-defined acceptance criteria in a clinical context.

Summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document states "Performance Evaluation Report" for various applications were submitted, but the content of these reports (i.e., the specific acceptance criteria and the results proving they were met) is not included in this 510(k) summary.

2. Sample size used for the test set and the data provenance: This information is not provided. The document states "No clinical study was required." The performance evaluations mentioned are likely internal verification and validation tests whose specifics are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Given that "No clinical study was required," it's unlikely a formal multi-expert ground truth establishment process for a clinical test set, as typically done for AI/ML diagnostic devices, was undertaken for this submission in a publicly available manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.

5. 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: This information is not provided. The document explicitly states "No clinical study was required."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states this is a "software solution intended to be used for viewing, manipulation, and storage of medical images" that "supports interpretation and evaluation of examinations within healthcare institutions." The listed applications provide "a tool for the user to perform..." or "a tool for the review and analysis..." which implies human-in-the-loop use. Standalone performance metrics are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.

8. The sample size for the training set: This information is not provided. The document is a 510(k) summary for a software device, not a detailed technical report on an AI/ML model's development.

9. How the ground truth for the training set was established: This information is not provided.

In conclusion, the supplied document is a regulatory submission summary focused on demonstrating substantial equivalence based on intended use and technological characteristics, rather than a detailed technical report of performance studies for an AI/ML device with specific acceptance criteria and proven results. For this type of information, one would typically need access to the full 510(k) submission, which is not publicly available in this format, or a peer-reviewed publication based on the device's clinical performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 24, 2019

Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA

Re: K183170

Trade/Device Name: uWS-CT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 28, 2019 Received: May 29, 2019

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 vou, 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

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

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

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

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183170

Device Name uWS-CT

Indications for Use (Describe)

uWS-CT is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.

The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating CT vascular images.

The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.

The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway.

The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in the brain.

The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.

The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.

The CT Dynamic Analysis application is intended to provide visualization of the CT datasets over time with the 3D/4D display modes.

The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk.

The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 a rounded square with a vertical line through the center. The logo is simple and modern, and the use of bold text and a strong symbol makes it easily recognizable.

510 (k) SUMMARY

K183170

1. Date of Preparation: May 28, 2019

Sponsor Identification 2.

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Establishment Registration Number: 3011015597

Contact Person: Xin Gao Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com

3. Identification of Proposed Device

Trade Name: uWS-CT Common Name: CT Image Post-Processing Software Model(s): uWS-CT

Regulatory Information Classification Name: Picture archiving and communications system Classification: II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology

4. Identification of Predicate Device(s)

Predicate Device 510(k) Number: K173001 Device Name: uWS-CT

Reference Device#1 510(k) Number: K103480 Device Name: THORACIC VCAR

Reference device#2 510(k) Number: K033326

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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 bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is made up of a thick, dark vertical line and a shorter horizontal line that extends from the top of the vertical line to the left.

Device Name: "Philips Plus" CT Scanner

Reference device#3 510(k) Number: K090546 Device Name: nordicICE Software

Reference device#4 510(k) Number: K113442 Device Name: 3Di including Viewing of Mammography images

Reference device#5 510(k) Number: K150843 Device Name: syngo.via

Reference device#6 510(k) Number: K120331 Device Name: syngo.CT Dynamic Angio

Reference device#7 510(k) Number: K133643 Device Name: syngo.CT Liver Analysis

Reference device#8 510(k) Number: K162025 Device Name: IntelliSpace Portal Platform

5. Device Description

This proposed device contains the following modifications/improvements in comparison to the predicate device uWS-CT:

Modified Indications for Use Statement;
Modified CT Lung Density Analysis, CT Heart and CT Calcium Scoring application;

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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern.

1. Added some advanced applications:
- . CT Brain Perfusion
- CT Dynamic Analysis
- . CT Bone Structure Analysis
- CT Liver Evaluation

6. Indications for use

The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver.
The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
. The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
. The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway.
. The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
. The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in brain.
. The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
. The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.
. The CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes.

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Image /page/7/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 line running through the middle of it. The overall design is clean and modern.

The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk.
. The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.

7. Summary of Technological Characteristics

uWS-CT is a medical diagnostic application for viewing, manipulation, 3D visualization, post-processing and comparison of medical images. After importing the DICOM image data into the system, the operator is able to perform image browsing and processing and can further obtain advanced information for diagnosis. This is identical to the predicate device.

The following tables compare the main features, principles of operation, fundamental scientific technology and intended use of uWS-CT when compared to the predicate devices.

Substantially Equivalent (SE) Comparison 8.

Both the proposed and predicate device have the same general information, such as Device Classification Name, Product Code, Classification Panel, etc. and visualization and measurement technological features:

Image communication
Hardware /OS
Patient Administration
Review 2D ●
Review 3D
Filming
. . . Fusion
Inner View
Visibility
ROI/VOI
MIP Display
Compare

The proposed and predicate device also have the same advanced applications in following:

CT Oncology
CT Dental Application
CT Colon Analysis ●
CT Vessel Analysis

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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other and are in bold, sans-serif font. To the right of the words is a stylized "U" symbol. The symbol is a dark gray color and has a white line running vertically through the center.

● CT Lung Nodule

The differences between the proposed and the predicate device are about advanced applications, and are listed as follows:

CT Lung density Analysis application has been modified, 6 new functions were added as follows. Substantial equivalence of these functions between the proposed and their corresponding reference device is discussed in Table 2.
- Lung Contour Editing
- . Pulmonary lobes Segmentation
- . Airway Segmentation
- . Airway Tree Extraction and Editing
- Airway Contour Editing
- . Statistical Analysis
CT Heart and CT Calcium Scoring applications have been modified. Substantial equivalence of these applications between the proposed and their corresponding reference device is discussed in Table 2.
The proposed device has added 4 new features to the predicate device. Substantial equivalence of these 4 features between the proposed and the corresponding reference device is also discussed in Table 2.
- . CT Brain Perfusion
- CT Dynamic Analysis
- CT Bone Structure Analysis
- . CT Liver Evaluation

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Item	Proposed DeviceuWS-CT	Predicate DeviceuWS-CT(K173001)	Remark
General
Device ClassificationName	Picture Archiving and Communications System	Picture Archiving and Communications System	Same
Product Code	LLZ	LLZ	Same
Regulation Number	21 CFR 892.2050	21 CFR 892.2050	Same
Device Class	II	II	Same
Classification Panel	Radiology	Radiology	Same
Advanced Application	Yes	Yes	The proposed device includes more applications, which is discussed in the following sections, than the predicate device. This difference will not impact the safety and effectiveness of the device.
Intended Use	uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.	uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing the segmentation and volumetric evaluation of suspicious lesions in lung or liver.	The intended use is supplemented. The proposed device includes more applications, which is discussed in the following sections, than the predicate device. This difference will not impact the safety and effectiveness of the device.
Item	Proposed Device	Predicate Device	Remark
	uWS-CT	uWS-CT(K173001)
	The CT Dental application is intended to provide theuser a tool to reconstruct panoramic and paraxial viewsof jaw. The CT Lung Density Analysis application is intendedto segment pulmonary, lobes, and airway, providing theuser quantitative parameters, structure information toevaluate the lung and airway. The CT Lung Nodule application is intended to providethe user a tool for the review and analysis of thoracic CTimages, providing quantitative and characterizinginformation about nodules in the lung in a single study,or over the time course of several thoracic studies. The CT Vessel Analysis application is intended toprovide a tool for viewing, manipulating, and evaluatingCT vascular images. The Inner view application is intended to perform avirtual camera view through hollow structures(cavities), such as vessels. The CT Brain Perfusion application is intended tocalculate the parameters such as: CBV, CBF, etc. inorder to analyze functional blood flow informationabout a region of interest (ROI) in brain. The CT Heart application is intended to segment heartand extract coronary artery .It also provides analysis ofvascular stenosis, plaque and heart function. The CT Calcium Scoring application is intended toidentify calcifications and calculate the calcium score. The CT Dynamic Analysis application is intended tosupport visualization of the CT datasets over time withthe 3D/4D display modes. The CT Bone Structure Analysis application is intendedto provide visualization and labels for the ribs and spine,and support batch function for intervertebral disk.	The CT Colon Analysis application isintended to provide the user a tool toenable easy visualization and efficientevaluation of CT volume data sets of thecolon. The CT Dental application is intended toprovide the user a tool to reconstructpanoramic and paraxial views of jaw. The CT Lung Density application isintended to provide the user a number ofdensity parameters and structureinformation for evaluating tomogramscans of the lung. The CT Lung Nodule application isintended to provide the user a tool for thereview and analysis of thoracic CTimages, providing quantitative andcharacterizing information about nodulesin the lung in a single study, or over thetime course of several thoracic studies. The CT Vessel Analysis application isintended to provide a tool for viewing,manipulating, and evaluating CT vascularimages. The Inner view application is intended toperform a virtual camera view throughhollow structures (cavities), such asvessels.
Item	Proposed DeviceuWS-CT	Predicate DeviceuWS-CT(K173001)	Remark
	The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.

Table 1 Comparison of general information

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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is composed of thick, vertical lines and a horizontal line at the top, creating a modern and abstract representation of the letter.

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Image /page/11/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 connected by a horizontal line at the top, creating a shape that resembles a shield or a stylized letter U.

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Application	Function name	ProposeddeviceuWS-CT	Predicate device:uWS-CT(K173001)	Reference device#1AW SERVER(K103480)	Remark
CT Lung densityAnalysis	Lung Segmentation	Yes	Yes	/	Same, no change
	Calculation of LungDensity	Yes	Yes	/	Same, no change
	Histogram Analysis	Yes	Yes	/	Same, no change
	Table Statistics	Yes	Yes	/	Same, no change
	VRT Protocol Display	Yes	Yes	/	Same, no change
	Save, Report, Print	Yes	Yes	/	Same, no change
	Lung Contour Editing	Yes	/	Yes	Same
	Pulmonary lobesSegmentation	Yes	/	Yes	Same
	Airway Segmentation	Yes	/	Yes	Same
	Airway Tree Extractionand Editing	Yes	/	Yes	Same
	Airway Contour Editing	Yes	/	Yes	Same
	Statistical Analysis	Yes	/	Yes	Same

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Application	Function name	Proposed deviceuWS-CT	Referencedevice#2"Philips Plus" CT Scanner(K033326)	Reference device#3nordicICE Software(K090546)	Remark
CT BrainPerfusion	Motion Correction	Yes	Yes	/	Same
Perfusion	Threshold basedsegmentation	Yes	Yes	/	Same
	Select the artery	Yes	Yes	/	Same
	Vessel Suppression	Yes	Yes	/	Same
	Calculating parameter map	Yes	/	Yes	Same
	Time-density curve analysis	Yes	Yes	/	Same
	Ischemic penumbra analysis	Yes	Yes	/	Same
	Image fusion	Yes	Yes	/	Same
	Symmetrical ROI analysis	Yes	Yes	/	Same
		Save, Report, Print	Yes	Yes	/

Application	Function name	Proposed deviceuWS-CT	Reference device#43Di including Viewing ofMammography images(K113442)	Remark
CT Heart	Multi-Phase Loading	Yes	Yes	Same
	Heart Chamber Segmentation	Yes	Yes	Same
	Coronary Artery Extraction	Yes	Yes	Same
	Editing Tools	Yes	Yes	Same
	Centerline Extraction	Yes	Yes	Same
	Stenosis Analysis	Yes	Yes	Same
	Plaque Analysis	Yes	Yes	Same
	Cardiac function Assessment	Yes	Yes	Same
	Save, Report, Print	Yes	Yes	Same

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Application	Function name	Proposed deviceuWS-CT	Reference device#43Di including Viewing ofMammography images(K113442)	Remark
CT Calcium Scoring	Calcium sites segmentation	Yes	Yes	Same
	Calculate Calcium score	Yes	Yes	Same
	Save, Report, Print	Yes	Yes	Same

Application	Function name	Proposed deviceuWS-CT	Predicate Device#5syngo.via(K150843)	Remark
CT Bone StructureAnalysis	Labeling Ribs	Yes	Yes	Same
	Labeling Spine	Yes	Yes	Same
	Batch	Yes	Yes	Same
	Save, Report, Print	Yes	Yes	Same

Application	Function name	Proposed deviceuWS-CT	Reference device#6syngo.CT Dynamic Angio(K120331)	Remark
CT Dynamic Analysis	Motion correction	Yes	Yes	Same
	Multiple phase viewing	Yes	Yes	Same
	Bone Removal	Yes	Yes	Same
	Dynamic CT datasets viewingin 3D/4D mode	Yes	Yes	Same
	Save, Report, Print	Yes	Yes	Same

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Application	Function name	Proposed deviceuWS-CT	Reference device#7:syngo.CT Liver Analysis(K133643)	Reference device#8IntelliSpace Portal Platform(K162025)	Remark
CT LiverEvaluation	Phase Selection	Yes	Yes	/	Same
	Liver Segmentation	Yes	Yes	/	Same
	Lesion Segmentation	Yes	Yes	/	Same
	Vessel Extraction	Yes	Yes	/	Same
	Vascular Editing	Yes	Yes	/	Same
	Liver Segments	Yes	/	Yes	Same
	Virtual Planning	Yes	Yes	/	Same
	RFA	Yes	/	Yes	Same
	Measurement	Yes	Yes	/	Same
	Save, Report, Print	Yes	Yes	/	Same

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Image /page/16/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 dark gray and has a white horizontal line through the middle. The logo is simple and modern in design.

9. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

Not Applicable to the proposed device, because the device is stand-alone software.

Electrical Safety and Electromagnetic Compatibility (EMC)

Not Applicable to the proposed device, because the device is stand-alone software.

Software Verification and Validation

Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). Those documentations include:

Software description
Hazard Analysis
· Software requirements specification (SRS)
Software Architecture Description
· Software Development Environment Description
Software Verification and Validation
· Cyber security Documents

Animal Study

No animal study was required.

Clinical Studies

No clinical study was required.

Performance Verification

Performance Evaluation Report for CT Lung Density Analysis
Performance Evaluation Report for CT Brain Perfusion
Performance Evaluation Report for CT Heart
Performance Evaluation Report for CT Calcium Scoring
. Performance Evaluation Report for CT Dynamic Analysis
Performance Evaluation Report for CT Bone Structure
Performance Evaluation Report for CT Liver Evaluation

Other Standards and Guidance

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Image /page/17/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 dark teal in color and has a white horizontal line running through the middle of it. The overall design is clean and modern.

NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
. ISO 14971 Medical devices - Application of risk management to medical devices (Edition 2.0, corrected version, 2007).
. IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015).

Summary

The features described in this premarket submission are supported with the results of the testing mentioned above; the uWS-CT was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.

10. Substantially Equivalent (SE) Conclusion

The proposed device is equivalent to the predicate device with regard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics, performance specification, device hazards as well as verification and validation results.

In summary, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device and reference devices.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).