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.

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.

AI/ML Overview

The provided text describes the performance data for three AI/ML algorithms integrated into the uOmnispace.CT software: Spine Labeling Algorithm, Rib Labeling Algorithm, and TAVR Analysis Algorithm.

Here's a breakdown of the acceptance criteria and study details for each:

1. Spine Labeling Algorithm

Acceptance Criteria Table:

Validation Type	Acceptance Criteria	Reported Device Performance	Meets Criteria?
Score based on ground truth	The average score of the proposed device results is higher than 4 points.	5.0 points	Yes

Study Proving Device Meets Acceptance Criteria:

Sample Size for Test Set: 120 subjects.
Data Provenance: Retrospective, with data collected from five major CT manufacturers (GE, Philips, Siemens, Toshiba, UIH). Clinical subgroups included U.S. (90 subjects) and Asia (30 subjects) for ethnicity.
Number of Experts for Ground Truth: At least two licensed physicians with U.S. credentials.
Qualifications of Experts: Licensed physicians with U.S. credentials.
Adjudication Method: Ground truth annotations were made by "well-trained annotators" using an interactive tool to set annotation points and assign anatomical labels. All ground truth was finally evaluated by two licensed physicians with U.S. credentials. This suggests a post-annotation review/adjudication by experts.
MRMC Comparative Effectiveness Study: No, this was a standalone performance evaluation of the algorithm against established ground truth.
Standalone Performance: Yes, the performance of the algorithm itself was evaluated based on a scoring system against ground truth.
Type of Ground Truth Used: Expert consensus (annotators + review by licensed physicians).
Sample Size for Training Set: Not specified, but stated that "The training data used for the training of the spine labeling algorithm is independent of the data used to test the algorithm."
How Ground Truth for Training Set was Established: Not specified beyond the implication that a ground truth process was followed for training data as well.

2. Rib Labeling Algorithm

Acceptance Criteria Table:

Validation Type	Acceptance Criteria	Reported Device Performance	Meets Criteria?
Score based on ground truth	The average score of the proposed device results is higher than 4 points.	5.0 points	Yes

Study Proving Device Meets Acceptance Criteria:

Sample Size for Test Set: 120 subjects.
Data Provenance: Retrospective, with data collected from five major CT manufacturers (GE, Philips, Siemens, Toshiba, UIH). Clinical subgroups included U.S. (80 subjects) and Asia (40 subjects) for ethnicity.
Number of Experts for Ground Truth: At least two licensed physicians with U.S. credentials.
Qualifications of Experts: Licensed physicians with U.S. credentials.
Adjudication Method: Ground truth annotations were made by "well-trained annotators" using an interactive tool to generate initial rib masks, which were then refined, and anatomical labels assigned. After the first round, annotators "checked each other's annotation." Finally, all ground truth was evaluated by two licensed physicians with U.S. credentials. This indicates a multi-step adjudication process.
MRMC Comparative Effectiveness Study: No, this was a standalone performance evaluation of the algorithm against established ground truth.
Standalone Performance: Yes, the performance of the algorithm itself was evaluated based on a scoring system against ground truth.
Type of Ground Truth Used: Expert consensus (annotators + cross-checking + review by licensed physicians).
Sample Size for Training Set: Not specified, but stated that "The training data used for the training of the rib labeling algorithm is independent of the data used to test the algorithm."
How Ground Truth for Training Set was Established: Not specified beyond the implication that a ground truth process was followed for training data as well.

3. TAVR Analysis Algorithm

Acceptance Criteria Table:

Validation Type	Acceptance Criteria	Reported Device Performance	Meets Criteria?
Verify the consistency with ground truth (Mean Landmark Error)	The mean landmark error between the proposed device results and ground truth is less than the threshold, 1 mm.	0.86 mm	Yes
Subjective Scoring of doctors with U.S. professional qualifications	The average score of the evaluation criteria is higher than 2.	3 points	Yes

Study Proving Device Meets Acceptance Criteria:

Sample Size for Test Set: 60 subjects.
Data Provenance: Retrospective. Clinical subgroups included Asia (25 subjects) and U.S. (35 subjects) for ethnicity, including data from U.S. Facility 1 (25 subjects) and U.S. Facility 2 (10 subjects).
Number of Experts for Ground Truth: At least two licensed physicians with U.S. credentials for the final evaluation of the ground truth.
Qualifications of Experts: Licensed physicians with U.S. credentials (specifically, "two MD with the American Board of Radiology Qualification" for the subjective scoring).
Adjudication Method: Ground truth annotations were made by "well-trained annotators." After the first round of annotation, they "checked each other's annotation." Finally, all ground truth was evaluated by two licensed physicians with U.S. credentials. This indicates a multi-step adjudication process.
MRMC Comparative Effectiveness Study: No, this was a standalone performance evaluation of the algorithm against established ground truth and subjective expert scoring.
Standalone Performance: Yes, the performance of the algorithm itself was evaluated based on landmark error and subjective expert scoring.
Type of Ground Truth Used: Expert consensus (annotators + cross-checking + review by licensed physicians).
Sample Size for Training Set: Not specified, but stated that "The training data used for the training of the post-processing algorithm is independent of the data used to test the algorithm."
How Ground Truth for Training Set was Established: Not specified beyond the implication that a ground truth process was followed for training data as well.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

-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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com

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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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

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

. 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 DeviceuOmnispace.CT	Predicate DeviceuWS-CT(K183170)	Remark
General
Intended Use	uOmnispace.CT is a software for viewing,manipulating, evaluating and analyzing medicalimages. It supports interpretation and evaluation ofexaminations within healthcare institutions. It hasthe following additional indications:The uOmnispace.CT Colon Analysisapplication is intended to provide the user a tool toenable easy visualization and efficient evaluation ofCT volume data sets of the colon. The uOmnispace.CT Dental application isintended to provide the user a tool to reconstructpanoramic and paraxial views of jaw. The uOmnispace.CT Lung Density Analysisapplication is intended to segment pulmonary, lobes,and airway, providing the user quantitativeparameters, structure information to evaluate thelung and airway. The uOmnispace.CT Lung Noduleapplication is intended to provide the user a tool forthe review and analysis of thoracic CT images,providing quantitative and characterizinginformation about nodules in the lung in a singlestudy, or over the time course of several thoracicstudies. The uOmnispace.CT Vessel Analysisapplication is intended to provide a tool for viewing,manipulating, and evaluating CT vascular images. The uOmnispace.CT Brain Perfusionapplication is intended to calculate the parameters	uWS-CT is a software solution intended to be usedfor viewing, manipulation, communication, andstorage of medical images. It supports interpretationand evaluation of examinations within healthcareinstitutions. It has the following additionalindications:The CT Colon Analysis application isintended to provide the user a tool to enable easyvisualization and efficient evaluation of CT volumedata sets of the colon. The CT Dental application is intended toprovide the user a tool to reconstruct panoramic andparaxial views of jaw. The CT Lung Density application isintended to provide the user a number of densityparameters and structure information for evaluatingtomogram scans of the lung. The CT Lung Nodule application isintended to provide the user a tool for the review andanalysis of thoracic CT images, providingquantitative and characterizing information aboutnodules in 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 vascular images. The CT Brain Perfusion application isintended to calculate the parameters such as: CBV,CBF, etc. in order to analyze functional blood flow	Substantial Equivalence.The proposed deviceincludes moreapplications, which arediscussed in the followingsections, than the predicatedevice. This differencewill not impact the safetyand effectiveness of thedevice.
Item	Proposed DeviceuOmnispace.CT	Predicate DeviceuWS-CT(K183170)	Remark
	such as: CBV, CBF, etc. in order to analyzefunctional blood flow information about a region ofinterest (ROI) in brain.	information about a region of interest (ROI) in thebrain.
	• The uOmnispace.CT Heart application isintended to segment heart and extract coronaryartery. It also provides analysis of vascular stenosis,plaque and heart function.	• The CT Heart application is intended tosegment heart and extract coronary artery. It alsoprovides analysis of vascular stenosis, plaque andheart function.
	• The uOmnispace.CT Calcium Scoringapplication is intended to identify calcifications andcalculate the calcium score.	• The CT Calcium Scoring application isintended to identify calcifications and calculate thecalcium score.
	• The uOmnispace.CT Dynamic Analysisapplication is intended to support visualization of theCT datasets over time with the 3D/4D displaymodes.	• The CT Dynamic Analysis application isintended to support visualization of the CT datasetsover time with the 3D/4D display modes.
	• The uOmnispace.CT Bone StructureAnalysis application is intended to providevisualization and labels for the ribs and spine, andsupport batch function for intervertebral disk.	• The CT Bone Structure Analysis applicationis intended to provide visualization and labels for theribs and spine, and support batch function forintervertebral disk.
	• The uOmnispace.CT Liver Evaluationapplication is intended to provide processing andvisualization for liver segmentation and vesselextraction. It also provides a tool for the user toperform liver separation and residual liver segmentsevaluation.	• The CT Liver Evaluation application isintended to provide processing and visualization forliver segmentation and vessel extraction. It alsoprovides a tool for the user to perform liverseparation and residual liver segments evaluation.
	• The uOmnispace.CT Dual Energy Analysisis a post-processing software package that acceptsUIH CT images acquired using different tubevoltages and/or tube currents of the same anatomicallocation. The uOmnispace.CT Dual Energyapplication is intended to provide information on thechemical composition of the scanned body materialsand/or contrast agents. Additionally it enables
Item	Proposed DeviceuOmnispace.CT	Predicate DeviceuWS-CT(K183170)	Remark
	images to be generated at multiple energies withinthe available spectrum.• The uOmnispace.CT CardiovascularCombined Analysis is an image analysis softwarepackage for evaluating contrast enhanced CTimages. The CT Cardiovascular Combined Analysisis intended to analyze vascular and cardiacstructures.It can be used in the qualitative andquantitative for the analysis of head-neck, abdomen,multi-body part combined, TAVR (TranscatheterAortic Valve Replacement) CT data as input for theplanning of cardiovascular procedures.

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Application	Function name	Proposed deviceuOmnispace.CT	Predicate device:uWS-CT(K183170)	Remark
uOmnispace.CT LungDensity 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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Application	Function Name	Proposed DeviceuOmnisapce.CT	PredicateDevice:uWS-CT(K183170)	Reference Device#5iSchema View's RAPID(K182130)	Remark
uOmnispace.CTBrain Perfusion	Motion Correction	Yes	Yes	/	Same
	Arterial Detection	Yes	Yes	/	Same
	Parameter MapCalculation	Yes	Yes	/	Same
	Time-density curveanalysis	Yes	Yes	/	Same
	Tmax	Yes	/	Yes	Functional SubstantialEquivalentNote 1
	Ischemic penumbraanalysis	Yes	/	Yes	Functional SubstantialEquivalentNote 2
	Symmetric ROI andROI Template	Yes	Yes	/	Same
	Save, Report, Print	Yes	Yes	/	Same

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Application	Function name	Proposed deviceuOmnispace.CT	Predicate device:uWS-CT(K183170)	Referencedevice#2UOmnispace(K230039)	Remark
uOmnispace.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 SubstantialEquivalentNote 3
	Save, Report, Print	Yes	Yes	/	Same

Application	Function name	Proposed device uOmnispace.CT	Predicate device: uWS-CT(K183170)	Remark
uOmnispace.CTCalcium Scoring	Calcium sites segmentation	Yes	Yes	Same
	Calculate Calcium score	Yes	Yes	Functional SubstantiallyEquivalentNote 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 deviceuOmnispace.CT	Predicate device:uWS-CT(K183170)	Remark
uOmnispace.CT BoneStructure Analysis	Labeling Ribs	Yes	Yes	Functional Substantial EquivalentNote 5
uOmnispace.CT BoneStructure Analysis	Labeling Spine	Yes	Yes	Functional Substantial EquivalentNote 6
uOmnispace.CT BoneStructure Analysis	Batch	Yes	Yes	Same
uOmnispace.CT BoneStructure Analysis	Save, Report, Print	Yes	Yes	Same
Application	Function name	Proposed deviceuOmnispace.CT	Predicate device:uWS-CT (K183170)	Remark
uOmnispace.CTDynamic Analysis	Motion correction	Yes	Yes	Same
uOmnispace.CTDynamic Analysis	Multiple phase viewing	Yes	Yes	Same
uOmnispace.CTDynamic Analysis	Bone Removal	Yes	Yes	Same
uOmnispace.CTDynamic Analysis	Data Loading and 3D/4DDisplay	Yes	Yes	Same
uOmnispace.CTDynamic Analysis	Artery and Vein Display	Yes	Yes	Same
uOmnispace.CTDynamic Analysis	Save, Report, Print	Yes	Yes	Same

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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 deviceuOmnispace.CT	Predicate deviceuWS-CT(K183170)	Reference device#3uOmnispace(K230039)	Referencedevice#4syngo.CTLiver Analysis(K133643)	Remark
uOmnispace.CTLiver Evaluation	Phase Selection	Yes	Yes	/	/	Same
	Liver Segmentation	Yes	Yes	/	/	Same
	Lesion Segmentation	Yes	Yes	/	/	Same
	Rib Segmentationandmanual 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 TerritoriesComputation andvisualization	Yes	/	/	Yes	Functional SubstantialEquivalentNote 7
	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 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 deviceuOmnispace.CT	Reference Device#1:uCT 760 with uWS-CT-DualEnergy Analysis, uCT 780with uWS-CT-Dual EnergyAnalysis (K230162)	Remark
uOmnispace.CTDualEnergy	Mono Energetic Image	Yes	Yes	Same
	Mixed Enhanced Image	Yes	Yes	Same
	CNR(Contrast Noise Ratio) Image	Yes	Yes	Same
	Base Material Images: IncludingWater-Iodine, Water-Calcium,Calcium-Iodine, Uric acid-Calcium,Water-HAP, Liver-Fat BaseMaterial Pair image.	Yes	Yes	Functional SubstantiallyEquivalentNote 8
	Image Registration	Yes	Yes	Same
	Effective Atomic Number Images• Component analysis ofkidney stones, uric acid stones ornon-uric acid stones• Component analysis ofjoint gout, uric acid gout or non-uric acid gout	Yes	Yes	Functional SubstantialEquivalentNote 9
	Electron Density Images	Yes	Yes	Same
	Virtual Non contrast Images	Yes	Yes	Same
	Save. Report, Print	Yes	Yes	Same

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Image /page/17/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 DeviceuOmnispace.CT	Predicate Device:uWS-CT(K183170)	Remark
uOmnispace.CT DentalApplication	Defining the Reference Plane	Yes	Yes	Same
	Plotting Panoramic Curve	Yes	Yes	Same
	Marking the Nerve Canals	Yes	Yes	Same
	Cross Sectional Operations	Yes	Yes	Same
	Dental VRT Display	Yes	Yes	Same
	Save, Report, Print (True sizeprinting)	Yes	Yes	Functional SubstantialEquivalentNote 10

Application	Function name	Proposed deviceuOmnispace.CT	Predicate device:uWS-CT(K183170)	Remark
uOmnispace.CT ColonAnalysis	Colon Segmentation andCenterline Calculate	Yes	Yes	Same
	Electronic Colon Cleansing	Yes	Yes	Same
	Manual Polyps Marking	Yes	Yes	Same
	Colon editing and Center Lineediting	Yes	Yes	Same
	Polyps' QuantitativeCalculation and Analysis	Yes	Yes	Same
	Virtual Endoscopy	Yes	Yes	Same
	Save, Report, Print	Yes	Yes	Same

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Image /page/18/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, dark teal font. To the right of the words is a stylized teal symbol that resembles a shield with a white line running vertically through the center.

Application	Function name	Proposed deviceuOmnispace.CT	Predicate device:uWS-CT(K183170)	Reference device#3uOmnispace(K230039)	Remark
uOmnispace.CT VesselAnalysis	Bone removal	Yes	Yes	/	Same
	Vessel and centerlinesExtraction	Yes	Yes	/	Same
	Semi-automatic vesselextraction	Yes	Yes	/	Same
	Vascular Measurement andvascular stenosis analysis	Yes	Yes	/	Same
	Save, Report, Print	Yes	Yes	/	Same
	Hyper Realistic Rendering	Yes	/	Yes	Same

Application	Function name	Proposed deviceuOmnispace.CT	Predicate device:uWS-CT(K183170)	Remark
uOmnispace.CT LungNodule	Marking Nodules	Yes	Yes	Same
	Follow-up Analysis	Yes	Yes	Same
	Lung Segmentation	Yes	Yes	Same
	Nodule Segmentation	Yes	Yes	Same
	Measurement for thesegmented nodule	Yes	Yes	Same
	Save, Report, Print	Yes	Yes	Same
Application	Function name	Proposed deviceuOmnispace.CT	Predicate device:uWS-CT(K183170)	Referencedevice#3Syngo.via(K170221)	Remark
uOmnispace.CTCardiovascularCombinedAnalysis	Vessel analysis:● Bone removal● Vessel and centerlines Extraction● Semi-automatic vessel extraction● Vascular Measurement and vascular -stenosis analysis● Hyper Realistic Rendering	Yes	Yes	/	Functional SubstantialEquivalentNote 11.
	Heart Analysis:● Multi-Phase Loading● Hyper Realistic Rendering● Heart Chamber Segmentation● Coronary Artery Extraction● Editing Tools● Centerline Extraction● Stenosis Analysis● Plaque Analysis● Cardiac function Assessment	Yes	Yes	/	Functional SubstantialEquivalentNote 12.
	Fusion Review:● The Combined Display of Heart and Vessels tissue	Yes	Yes	/	Same
TAVR Evaluation :• Automatic Aorticannulus location and manuallycorrection• Automatic Coronaryostia Location and manuallycorrection• Multi-parameterCalculation	Yes	/	Yes	Functional SubstantialEquivalentNote 13
Save, Report, Print	Yes	Yes	/	Same

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Image /page/19/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 blue. The logo is simple and modern.

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Image /page/20/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 with a vertical line running through the center. The logo is simple and modern in design.

Note 1:

Compared to reference device, the parameter principle and the functional implementation mode of Thax is consistent with RAPID. Additional verification tests were carried out to demonstrate that uOmissace. T vields acurate quantitative perfusion parameters. Therefore, this technological difference does not raise new issues of safety and effectiveness as compared to RAPID.

Note 2:

Compared to reference device, the function in Penumbra Analysis is consistent with RAPID. Additional verification tests were carried out to demonstrate that uOmnispace. Therefore parameters. Therefore, this technological difference does not raise new issues of safety and effectiveness as compared to RAPID.

Note 3:

Compared to predicate device add the calculation of parameters related to the left and right atria. These calculation is similar to the calculation of registered ventricular parameters. This difference between the predicate device doesn't impact the safety and effectiveness of the proposed device.

Note 4:

Compared to predicate device, the proposed device adds the computed Agatston Score to cited literature called Distribution of Coronary Artery Calcium by Race, Gender, and Age. The added function supports to compare the CAC between the normal people based on MESA database. The operating principle and the same, this difference between the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.

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Image /page/21/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, dark teal-colored icon that resembles a shield or a stylized letter 'U' with a vertical line running through the center.

Note 5:

Compared to predicate device, the proposed device optimizes a new algorithm based on deep learning. This algorithm supports the same function as uWS-CT (K183170). This difference between the predicate device doesn't impact the safety and effectiveness of the proposed device.

Note 6:

Note 7:

Compared to predicate device, the proposed device scomputation and visualization based on vessel branches. The operating principle and the scientific technology are the same. There would be no clinically significant difference in the proposed device.

Note 8:

Compared to predicate device, the proposed device supports the generation of more base material pains. There is no change in algorithm and this algorithm support the same finction as K230162. This difference between the proposed device doesn't impact the safety and effectiveness of the proposed device.

Note 9:

Compared to prodicate device, the proposed device increased the volume calculation based on the effective Atomic Number Image, the volume calculation is the process of pixel counting. There is no change in algorithm support the same function as K230162. This difference between the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.

Note 10:

Compared to predicate device adds twe size printing, there is no change in operating principle and it is only through the ratio of the printed image scale to the real physical scale. The print effect is obtained. This difference between the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.

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Image /page/22/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 symbol that resembles a shield or a letter 'U' with a vertical line running through the center, creating a negative space 'I' shape. The logo is simple and modern in design.

Note 11:

For uOmnispace.CT Cardiovascular Combined Analysis application, it integrates uOmnispace.CT Vessel Analysis application and uOmnispace.CT Heart application, these two applications are the CT Vessel Analysis application and the CT Heart application in K183170. There would be no impact on safety and effectiveness of this function.

Note 12:

The function of cardiac analysis refer to uOmnispace.CT Heart.

For u0mnispace.CT Cardiovascular Combined Analysis application, it integrates uOmnispace.CT Vessel Analysis application and uOmnispace.CT Heart application, these two applications are the CT Vessel Analysis application and the CT Heart application in K183170. There would be no impact on safety and effectiveness of this function.

Note 13:

For uOmnispace.CT Cardiovascular Combined Analysis application is substantively equivalent to the predicate device Syngo. via (K17022). Additionally, the proposed device can provide the left and right coronary ostium to annulus. Testing was performed to ensure the measurements meet the predetermined acceptance values the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.

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Image /page/23/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 divided into two halves by a vertical white line. The logo is simple and modern, with a focus on the company name and a unique visual element.

8. 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 the Basic Documentation Level, including:

· Software Description
· Device Hazard Analysis
· Software Requirements Specification (SRS)
· Software Architecture Design Chart
· Software Development Environment Description
Software Verification and Validation
· Cybersecurity Documents

Animal Study

No animal study was required.

Clinical Studies

No clinical study was required.

Performance Verification

There are three algorithms based on ML/AI method:

Spine labeling algorithm
Rib labeling algorithm
TAVR analysis algorithm

More information about the ML/AI algorithm is as follows:

1. Spine labeling Algorithm

The performance testing for deep learning-based spine labeling algorithm was performed on 120 subjects (data shown in Table 8-2) during the product development.

Acceptance Criteria ●

The validation type and acceptance criteria is shown in the Table 8-1 below:

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Image /page/24/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 "U" shape has a vertical line running through the center and a horizontal line across the top, creating a cross-like shape within the "U".

	Table 8-1. Validation type and acceptance criteria

Validation Type	Acceptance Criteria
Score based on ground truth	The average score of the proposed deviceresults is higher than 4 points.

. Testing Data Information

Equipment and Protocols 1)

CT data were acquired from five major manufacturers (GE, Phillips, Siemens, Toshiba, UIH), and with tube voltage of 80 - 140kVp, slice thickness of 0.625-3.75 mm.

Clinical Subgroup Information 2)

The subgroup information of testing data is summarized below.

Subgroup	Details of Each Subgroup	Sample Size
Ethnicity	U.S.	90
	Asia	30
Age	[22, 25]	4
	[26, 40]	11
	[41, 60]	25
	[61, 75]	52
	[76, 100]	9
	Unknown	18
	Gender	Female
Male		63
Unknown		7
BMI (kg/m(2))	< 18.5	6
	[18.5, 25)	19
	>=25	37
	Unknown	58

Table 8-2. Testing data subgroup information

. Performance Testing Summary

The average score of the proposed device results to be validated is 5 points, which is greater than 4 points. Meanwhile, the subgroup analysis shows that (Table 8-3) the proposed device algorithm has good generalization in different subgroups.

Table 6-3. Subgroup performance test
Ethnicity	Average Score of All Test Dataset
U.S.	5.0
Asia	5.0
Age	Average Score of All Test Dataset
[22, 25]	5.0
[26, 40]	5.0
[41, 60]	5.0
[61,75]	5.0
[76, 100]	5.0
Unknown	5.0
Gender	Average Score of All Test Dataset
Female	5.0
Male	5.0
Unknown	5.0

Table 8-3. Subgroup performance test

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Image /page/25/Picture/1 description: The image shows 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 dark blue. The logo is simple and modern.

BMI (kg/m(2))	Average Score of All Test Dataset
< 18.5	5.0
[18.5, 25)	5.0
>=25	5.0
Unknown	5.0

. Standard Annotation Process

For ground truth annotations, all ground truth are annotated by well-trained annotators.

The annotators use an interactive tool to observe the image, and then set annotation points near the center of vertebral body and assign anatomical labels. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.

. Testing & Training Data Independence

The training data used for the training of the spine labeling algorithm is independent of the data used to test the algorithm.

2. Rib labeling Algorithm

The performance testing for deep learning-based rib labeling algorithm was performed on 120 subjects (data shown in Table 8-5) during the product development.

. Acceptance Criteria

The validation type and acceptance criteria is shown in the Table 8-4 below:

Validation Type	Acceptance Criteria
Score based on ground truth	The average score of the proposed deviceresults is higher than 4 points.

Table 8-4. Validation type and acceptance criteria

. Testing Data Information

Equipment and Protocols 1)

CT data were acquired from five major manufacturers (GE, Phillips, Siemens, Toshiba, UIH), and with tube voltage of 80 - 140kVp, slice thickness of 0.625-3.75 mm.

2) Clinical Subgroup Information

The subgroup information of testing data is summarized below.

Table 8-5. Testing data subgroup information
Subgroup	Details of each subgroup	Sample Size
Ethnicity	U.S.	80
	Asia	40
Age	[22, 25]	4
	[26, 40]	14
	[41, 60]	25
	[61, 75]	46
	[76, 100]	18
	Unknown	13

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Image /page/26/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED" and "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 logo is a dark teal.

Gender	Female	54
	Male	66
BMI (kg/m(2))	< 18.5	10
	[18.5, 25)	23
	>=25	36
	Unknown	51

. Performance Testing Summary

The average score of the proposed device results to be validated is 5 points, which is greater than 4 points. Meanwhile, the subgroup analysis shows that (Table 8-6) the proposed device algorithm has good generalization in different subgroups.

Ethnicity	Average Score of All Test Dataset
U.S.	5.0
Asia	5.0
Age	Average Score of All Test Dataset
[22, 25]	5.0
[26, 40]	5.0
[41, 60]	5.0
[61, 75]	5.0
[76, 100]	5.0
Unknown	5.0
Gender	Average Score of All Test Dataset
Female	5.0
Male	5.0
BMI (kg/m(2))	Average Score of All Test Dataset
< 18.5	5.0
[18.5, 25)	5.0
>=25	5.0
Unknown	5.0

Table 8-6. Subgroup performance test

. Standard Annotation Process

For ground truth annotations, all ground truth are annotated by well-trained annotators. A threshold based interactive tool is used to generate initial rib mask, then annotators will refine the rib mask and assign anatomical labels. After the first round annotation, they will check each other's annotation. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.

. Testing & Training Data Independence

The training data used for the training of the rib labeling algorithm is independent of the data used to test the algorithm.

3. TAVR analysis algorithm

The performance testing for the AI-based TAVR analysis algorithm was performed on 60 subjects (data shown in Table 8-8) during the product development.

● Acceptance Criteria

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Image /page/27/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, which is dark gray. Inside the "U" shape is a white line that forms a "T" shape.

The validation type and acceptance criteria are shown in Table 8-7 below:

Validation Type	Acceptance Criteria
Verify the consistency with ground truth	The mean landmark error between the proposed device results and ground truth is less than the threshold, 1 mm.
Subjective Scoring of doctors with U.S. professional qualifications	The average score of the evaluation criteria is higher than 2.

9 7 Validetion tu and .............................................................................................................................................................................. . .

Testing Data Information .

Information of data	Details of each subgroup	Sample size
Sex	Male	29
	Female	21
	Unknown	10
Age	[40, 60)	9
	[60, 70)	16
	[70, 80)	14
	[80, 100)	11
	Unknown	10
Ethnicity	Asia	25
	U.S.	35
US. Facility	U.S. Facility 1	25
	U.S. Facility 2	10

Table 8-8, Testing data information

. Performance Testing Summary:

The Mean Landmark Error for all data is 0.86 mm, which is less than 1mm. The average scores of two MD with the American Board of Radiology Qualification on the testing data set is 3, which is higher than 2. Meanwhile, the subgroup analysis shows that (Table 8-9) the performance of the algorithm consists of different subgroups.

All	Mean Landmark Error (mm)	Average Score
All data	0.86	3
Age	Mean Landmark Error (mm)	Average Score
[40, 60)	0.888	3
[60, 70)	0.818	3
[70, 80)	0.907	3
[80, 100)	0.845	3
unknown	0.85	3
Gender	Mean Landmark Error (mm)	Average Score
Female	0.9	3
Male	0.834	3
Unknown	0.85	3
Ethnicity	Mean Landmark Error (mm)	Average Score
Asia	0.852	3
U.S.	0.866	3
US. Facility	Mean Landmark Error (mm)	Average Score
U.S. Facility 1	0.872	3

Table 8-9. Subgroup performance test

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Image /page/28/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 "U" symbol, which is dark gray. The logo is simple and modern.

YY NThe States of the Career of the Comments of the Children 0.85J.S. Facility
---------------------------------------------------------------------------------------------	--	--

. Standard Annotation Process

For ground truth annotations, all ground truth are annotated by well-trained annotators. After the first round of annotation, they will check each other's annotation. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.

. Testing & Training Data Independence

The training data used for the training of the post-processing algorithm is independent of the data used to test the algorithm.

Other Standards and Guidance

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 uOmnispace.CT was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.

9. 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).