uOmnispace.CT

K233209 · Shanghai United Imaging Healthcare Co., Ltd. · QIH · May 17, 2024 · Radiology

Device Facts

• Record ID: K233209
• Device Name: uOmnispace.CT
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: QIH · Radiology
• Decision Date: May 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: -The uOmnispace.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 uOmnispace.CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. -The uOmnispace.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 uOmnispace.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 uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, and evaluating CT vascular images. -The uOmnispace.CT Brain Perfusion 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 uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. -The uOmnispace.CT Calcium Scoring application is intended to identify calcifications and calculate the calcium soore. -The uOmnispace.CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes. -The uOmnispace.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 uOmnispace. CT Liver Evaluation application is intended to 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. -The uOmnispace. CT Dual Energy 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 u0mnispace.CT Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum. -The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures. It can be used in the qualitative and quantitative for the analysis of head-neck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures.

Device Story

uOmnispace.CT is a standalone post-processing software platform for CT image analysis; operates in healthcare institutions; used by clinicians for diagnostic support. Inputs: CT volume datasets. Processing: includes automated segmentation, labeling, and quantification algorithms (e.g., spine/rib labeling, TAVR analysis, perfusion parameter calculation). Outputs: reconstructed views, quantitative parameters, segmented structures, and analysis reports. Clinical impact: assists in visualization, characterization of nodules, vascular/cardiac assessment, and procedural planning (e.g., TAVR). Benefits: provides efficient, standardized quantitative analysis of complex CT data to aid clinical decision-making.

Clinical Evidence

No clinical studies were required. Performance was established via bench testing and software verification/validation. ML/AI algorithms (spine labeling, rib labeling, TAVR analysis) were validated on datasets (n=60-120) using ground truth comparisons and subjective scoring by licensed physicians. Spine/rib labeling achieved average scores >4/5. TAVR analysis showed mean landmark error of 0.86 mm (<1 mm threshold) and average physician scores >2/3.

Technological Characteristics

Standalone software; DICOM-compliant; utilizes deep learning-based algorithms for spine/rib labeling and TAVR analysis. Complies with NEMA PS 3.1-3.20, ISO 14971, and IEC 62304 standards. No hardware components; no biocompatibility or electrical safety requirements.

Indications for Use

Indicated for healthcare professionals to view, manipulate, evaluate, and analyze CT medical images for diagnostic support. Applications include colon, dental, lung density/nodule, vessel, brain perfusion, heart, calcium scoring, dynamic analysis, bone structure, liver, dual energy, and cardiovascular combined analysis (including TAVR planning).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• uWS-CT (K183170)

Reference Devices

• uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis (K230162)
• uOmnispace (K230039)
• syngo.CT Cardiac Planning (K170221)
• syngo.CT Liver Analysis (K133643)
• iSchema View's RAPID (K182130)

Submission Summary (Full Text)

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

## Re: K233209

Trade/Device Name: uOmnispace.CT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: April 12, 2024 Received: April 12, 2024

May 17, 2024

## 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, PhD Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K233209

Device Name uOmnispace.CT

### Indications for Use (Describe)

uOmnispace. CT is a software for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additions: -The uOmnispace. 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 uOmnispace. CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. -The uOmnispace. 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 uOmnispace.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 uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, and evaluating CT vascular images. -The uOmnispace. CT Brain Perfusion 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 uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. -The uOmnispace. CT Calcium Scoring application is intended to identify calcifications and calculate the calcium soore. -The uOmnispace. CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes. -The uOmnispace.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 uOmnispace. CT Liver Evaluation application is intended to 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.

-The uOmnispace. CT Dual Energy 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 u0mnispace.CT Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum.

-The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures. It can be used in the qualitative and quantitative for the analysis of head-neck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures.

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)

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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern.

### 510 (k) SUMMARY K233209

- 1. Date of Preparation: May 16, 2024
# 2. Sponsor Identification

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: [phone]-5386 Fax: [phone] Email: [e-mail]

# 3. Identification of Proposed Device

Trade Name: uOmnispace.CT Common Name: Medical image management and processing system Model: uOmnispace.CT

## Regulatory Information Classification Name: Medical image management and processing system Classification: II

Product Code: QIH Regulation Number: 21 CFR 892.2050 Review Panel: Radiology

# 4. Identification of Predicate Device(s)

Predicate Device 510(k) Number: K183170 Common Name: Medical image management and processing system Model: uWS-CT

## Regulatory Information

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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" shape, which is dark gray. The logo is simple and modern in design.

Classification Name: Medical image management and processing system Classification: II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology

Reference Device#1 510(k) Number: K230162 Device Name: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis

Reference Device#2 510(k) Number: K230039 Device Name: uOmnispace

Reference Device#3 510(k) Number: K170221 Device Name: syngo.CT Cardiac Planning

Reference Device#4 510(k) Number: K133643 Device Name: syngo.CT Liver Analysis

Reference Device#5 510(k) Number: K182130 Device Name: iSchema View's RAPID

# 5. Device Description

The uOmnispace.CT is a post-processing software based on the uOmnispace platform for viewing, manipulating, evaluating and analyzing medical images, can run alone or with other advanced commercially cleared applications.

uOmnispace.CT contains the following applications:

- uOmnispace.CT Calcium Scoring ●
- uOmnispace.CT Lung Nodule ●
- uOmnispace.CT Colon Analysis
- . uOmnispace.CT Lung Density Analysis

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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" 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. The logo is simple and modern in design.

- uOmnispace.CT Dental Application ●
- . uOmnispace.CT Bone Structure Analysis
- uOmnispace.CT Dual Energy
- . uOmnispace.CT Vessel Analysis
- uOmnispace.CT Heart
- . uOmnispace.CT Brain Perfusion
- uOmnispace.CT Dynamic Analysis
- . uOmnispace.CT Liver Evaluation
- . uOmnispace.CT Cardiovascular Combined Analysis

# 6. Indications for use

uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

- . The uOmnispace.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 uOmnispace.CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
- . The uOmnispace.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 uOmnispace.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 uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images.
- . The uOmnispace.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 uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
- . The uOmnispace.CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.
- . The uOmnispace.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 shows the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" shape, also in a bold, sans-serif font, with a vertical line running through the center.

- The uOmnispace.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 uOmnispace.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.
- . The uOmnispace.CT Dual Energy 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 uOmnispace.CT Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum.
- . The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures. It can be used in the qualitative and quantitative for the analysis of headneck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures.

### Summary of Technological Characteristics 7.

The technology characteristics of uOmnispace.CT, reflected in this 510(k) submission are substantially equivalent to those of the predicate devices.

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

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Image /page/8/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 icon that resembles the letter "U" with a vertical line running through the center, creating a negative space "I" shape. The icon is a solid color, providing a visual contrast to the white background.

| Item | Proposed Device<br>uOmnispace.CT | Predicate Device<br>uWS-CT(K183170) | Remark |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Intended Use | uOmnispace.CT is a software for viewing,<br>manipulating, evaluating and analyzing medical<br>images. It supports interpretation and evaluation of<br>examinations within healthcare institutions. It has<br>the following additional indications:<br>The uOmnispace.CT Colon Analysis<br>application is intended to provide the user a tool to<br>enable easy visualization and efficient evaluation of<br>CT volume data sets of the colon. The uOmnispace.CT Dental application is<br>intended to provide the user a tool to reconstruct<br>panoramic and paraxial views of jaw. The uOmnispace.CT Lung Density Analysis<br>application is intended to segment pulmonary, lobes,<br>and airway, providing the user quantitative<br>parameters, structure information to evaluate the<br>lung and airway. The uOmnispace.CT Lung Nodule<br>application is intended to provide the user a tool for<br>the review and analysis of thoracic CT images,<br>providing quantitative and characterizing<br>information about nodules in the lung in a single<br>study, or over the time course of several thoracic<br>studies. The uOmnispace.CT Vessel Analysis<br>application is intended to provide a tool for viewing,<br>manipulating, and evaluating CT vascular images. The uOmnispace.CT Brain Perfusion<br>application is intended to calculate the parameters | uWS-CT is a software solution intended to be used<br>for viewing, manipulation, communication, and<br>storage of medical images. It supports interpretation<br>and evaluation of examinations within healthcare<br>institutions. It has the following additional<br>indications:<br>The CT Colon Analysis application is<br>intended to provide the user a tool to enable easy<br>visualization and efficient evaluation of CT volume<br>data sets of the colon. The CT Dental application is intended to<br>provide the user a tool to reconstruct panoramic and<br>paraxial views of jaw. The CT Lung Density application is<br>intended to provide the user a number of density<br>parameters and structure information for evaluating<br>tomogram scans of the lung. The CT Lung Nodule application is<br>intended to provide the user a tool for the review and<br>analysis of thoracic CT images, providing<br>quantitative and characterizing information about<br>nodules in the lung in a single study, or over the<br>time course of several thoracic studies. The CT Vessel Analysis application is<br>intended to provide a tool for viewing, manipulating,<br>and evaluating CT vascular images. The CT Brain Perfusion application is<br>intended to calculate the parameters such as: CBV,<br>CBF, etc. in order to analyze functional blood flow | Substantial Equivalence.<br>The proposed device<br>includes more<br>applications, which are<br>discussed in the following<br>sections, than the predicate<br>device. This difference<br>will not impact the safety<br>and effectiveness of the<br>device. |
| Item | Proposed Device<br>uOmnispace.CT | Predicate Device<br>uWS-CT(K183170) | Remark |
| | such as: CBV, CBF, etc. in order to analyze<br>functional blood flow information about a region of<br>interest (ROI) in brain. | information about a region of interest (ROI) in the<br>brain. | |
| | • The uOmnispace.CT Heart application is<br>intended to segment heart and extract coronary<br>artery. It also provides analysis of vascular stenosis,<br>plaque and heart function. | • The CT Heart application is intended to<br>segment heart and extract coronary artery. It also<br>provides analysis of vascular stenosis, plaque and<br>heart function. | |
| | • The uOmnispace.CT Calcium Scoring<br>application is intended to identify calcifications and<br>calculate the calcium score. | • The CT Calcium Scoring application is<br>intended to identify calcifications and calculate the<br>calcium score. | |
| | • The uOmnispace.CT Dynamic Analysis<br>application is intended to support visualization of the<br>CT datasets over time with the 3D/4D display<br>modes. | • The CT Dynamic Analysis application is<br>intended to support visualization of the CT datasets<br>over time with the 3D/4D display modes. | |
| | • The uOmnispace.CT Bone Structure<br>Analysis application is intended to provide<br>visualization and labels for the ribs and spine, and<br>support batch function for intervertebral disk. | • The CT Bone Structure Analysis application<br>is intended to provide visualization and labels for the<br>ribs and spine, and support batch function for<br>intervertebral disk. | |
| | • The uOmnispace.CT Liver Evaluation<br>application is intended to provide processing and<br>visualization for liver segmentation and vessel<br>extraction. It also provides a tool for the user to<br>perform liver separation and residual liver segments<br>evaluation. | • The CT Liver Evaluation application is<br>intended to provide processing and visualization for<br>liver segmentation and vessel extraction. It also<br>provides a tool for the user to perform liver<br>separation and residual liver segments evaluation. | |
| | • The uOmnispace.CT Dual Energy Analysis<br>is a post-processing software package that accepts<br>UIH CT images acquired using different tube<br>voltages and/or tube currents of the same anatomical<br>location. The uOmnispace.CT Dual Energy<br>application is intended to provide information on the<br>chemical composition of the scanned body materials<br>and/or contrast agents. Additionally it enables | | |
| Item | Proposed Device<br>uOmnispace.CT | Predicate Device<br>uWS-CT(K183170) | Remark |
| | images to be generated at multiple energies within<br>the available spectrum.<br>• The uOmnispace.CT Cardiovascular<br>Combined Analysis is an image analysis software<br>package for evaluating contrast enhanced CT<br>images. The CT Cardiovascular Combined Analysis<br>is intended to analyze vascular and cardiac<br>structures.It can be used in the qualitative and<br>quantitative for the analysis of head-neck, abdomen,<br>multi-body part combined, TAVR (Transcatheter<br>Aortic Valve Replacement) CT data as input for the<br>planning of cardiovascular procedures. | | |

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Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark blue with a white horizontal line through the middle. The logo is simple and modern.

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Image /page/10/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, dark blue icon that resembles the letter "U" with a horizontal line through the middle, creating a shape that also resembles the letter "I".

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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 a bold, sans-serif font. To the right of the words is a stylized "U" shape that is divided into three sections by two vertical white lines. The logo is simple and modern, and the use of bold font and geometric shapes gives it a strong visual impact.

| Application | Function name | Proposed device<br>uOmnispace.CT | Predicate device:<br>uWS-CT(K183170) | Remark |
|----------------------------------------|------------------------------------|----------------------------------|--------------------------------------|--------|
| uOmnispace.CT Lung<br>Density Analysis | Lung Segmentation | Yes | Yes | Same |
| | Lung Density Analysis | Yes | Yes | Same |
| | Lung Contour Editing | Yes | Yes | Same |
| | Pulmonary lobes Segmentation | Yes | Yes | Same |
| | Airway Segmentation | Yes | Yes | Same |
| | Airway Tree Extraction and Editing | Yes | Yes | Same |
| | Airway Contour Editing | Yes | Yes | Same |
| | Statistical Analysis | Yes | Yes | Same |
| | Save, Report, Print | Yes | Yes | Same |

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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 a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue with a white vertical line running through the center. The logo is simple and modern in design.

| Application | Function Name | Proposed Device<br>uOmnisapce.CT | Predicate<br>Device:<br>uWS-CT<br>(K183170) | Reference Device#5<br>iSchema View's RAPID<br>(K182130) | Remark |
|----------------------------------|-----------------------------------|----------------------------------|---------------------------------------------|---------------------------------------------------------|------------------------------------------------|
| uOmnispace.CT<br>Brain Perfusion | Motion Correction | Yes | Yes | / | Same |
| | Arterial Detection | Yes | Yes | / | Same |
| | Parameter Map<br>Calculation | Yes | Yes | / | Same |
| | Time-density curve<br>analysis | Yes | Yes | / | Same |
| | Tmax | Yes | / | Yes | Functional Substantial<br>Equivalent<br>Note 1 |
| | Ischemic penumbra<br>analysis | Yes | / | Yes | Functional Substantial<br>Equivalent<br>Note 2 |
| | Symmetric ROI and<br>ROI Template | Yes | Yes | / | Same |
| | Save, Report, Print | Yes | Yes | / | Same |

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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 words is a stylized letter "U" that is also in a bold font. The color of the logo is a dark gray.

| Application | Function name | Proposed device<br>uOmnispace.CT | Predicate device:<br>uWS-CT<br>(K183170) | Reference<br>device#2<br>UOmnispace<br>(K230039) | Remark |
|-------------------------|-----------------------------|----------------------------------|------------------------------------------|--------------------------------------------------|------------------------------------------------|
| uOmnispace.<br>CT Heart | Multi-Phase Loading | Yes | Yes | / | Same |
| | Hyper Realistic Rendering | 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 | / | Functional Substantial<br>Equivalent<br>Note 3 |
| | Save, Report, Print | Yes | Yes | / | Same |

| Application | Function name | Proposed device uOmnispace.CT | Predicate device: uWS-CT(K183170) | Remark |
|----------------------------------|----------------------------|-------------------------------|-----------------------------------|--------------------------------------------------|
| uOmnispace.CT<br>Calcium Scoring | Calcium sites segmentation | Yes | Yes | Same |
| | Calculate Calcium score | Yes | Yes | Functional Substantially<br>Equivalent<br>Note 4 |
| | Save, Report, Print | Yes | Yes | Same |

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Image /page/14/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 icon that resembles a shield or a letter "U" with a vertical line running through the center. The logo is simple and modern in design.

| Application | Function name | Proposed device<br>uOmnispace.CT | Predicate device:<br>uWS-CT(K183170) | Remark |
|------------------------------------------|-----------------------------------|----------------------------------|---------------------------------------|---------------------------------------------|
| uOmnispace.CT Bone<br>Structure Analysis | Labeling Ribs | Yes | Yes | Functional Substantial Equivalent<br>Note 5 |
| uOmnispace.CT Bone<br>Structure Analysis | Labeling Spine | Yes | Yes | Functional Substantial Equivalent<br>Note 6 |
| uOmnispace.CT Bone<br>Structure Analysis | Batch | Yes | Yes | Same |
| uOmnispace.CT Bone<br>Structure Analysis | Save, Report, Print | Yes | Yes | Same |
| Application | Function name | Proposed device<br>uOmnispace.CT | Predicate device:<br>uWS-CT (K183170) | Remark |
| uOmnispace.CT<br>Dynamic Analysis | Motion correction | Yes | Yes | Same |
| uOmnispace.CT<br>Dynamic Analysis | Multiple phase viewing | Yes | Yes | Same |
| uOmnispace.CT<br>Dynamic Analysis | Bone Removal | Yes | Yes | Same |
| uOmnispace.CT<br>Dynamic Analysis | Data Loading and 3D/4D<br>Display | Yes | Yes | Same |
| uOmnispace.CT<br>Dynamic Analysis | Artery and Vein Display | Yes | Yes | Same |
| uOmnispace.CT<br>Dynamic Analysis | Save, Report, Print | Yes | Yes | Same |

{15}------------------------------------------------

Image /page/15/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, sans-serif font. The color of the logo is a dark teal.

| Application | Function name | Proposed device<br>uOmnispace.CT | Predicate device<br>uWS-CT<br>(K183170) | Reference device#3<br>uOmnispace<br>(K230039) | Reference<br>device#4<br>syngo.CT<br>Liver Analysis<br>(K133643) | Remark |
|-----------------------------------|----------------------------------------------------------|----------------------------------|-----------------------------------------|-----------------------------------------------|------------------------------------------------------------------|------------------------------------------------|
| uOmnispace.CT<br>Liver Evaluation | Phase Selection | Yes | Yes | / | / | Same |
| | Liver Segmentation | Yes | Yes | / | / | Same |
| | Lesion Segmentation | Yes | Yes | / | / | Same |
| | Rib Segmentation<br>and<br>manual correction | 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 |
| | Vascular Territories<br>Computation and<br>visualization | Yes | / | / | Yes | Functional Substantial<br>Equivalent<br>Note 7 |
| | Measurement | Yes | Yes | / | / | Same |
| | Save, Report, Print | Yes | Yes | / | / | Same |

{16}------------------------------------------------

Image /page/16/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 logo that resembles a shield or a letter 'U' with a vertical line running through the center, creating a negative space 'I' shape.

| Application | Function name | Proposed device<br>uOmnispace.CT | Reference Device#1:<br>uCT 760 with uWS-CT-Dual<br>Energy Analysis, uCT 780<br>with uWS-CT-Dual Energy<br>Analysis (K230162) | Remark |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| uOmnispace.CT<br>Dual<br>Energy | Mono Energetic Image | Yes | Yes | Same |
| | Mixed Enhanced Image | Yes | Yes | Same |
| | CNR(Contrast Noise Ratio) Image | Yes | Yes | Same |
| | Base Material Images: Including<br>Water-Iodine, Water-Calcium,<br>Calcium-Iodine, Uric acid-Calcium,<br>Water-HAP, Liver-Fat Base<br>Material Pair image. | Yes…