Who is the manufacturer of uCT ATLAS with uWS-CT-Dual Energy Analysis?

Shanghai United Imaging Healthcare Co., Ltd. filed the 510(k) submission for uCT ATLAS with uWS-CT-Dual Energy Analysis (K203448).

What is the FDA product code for uCT ATLAS with uWS-CT-Dual Energy Analysis?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for uCT ATLAS with uWS-CT-Dual Energy Analysis?

510(k) clearance (submission type: Traditional).

Does uCT ATLAS with uWS-CT-Dual Energy Analysis use AI or machine learning?

Yes. uCT ATLAS with uWS-CT-Dual Energy Analysis (K203448) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like uCT ATLAS with uWS-CT-Dual Energy Analysis?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like uCT ATLAS with uWS-CT-Dual Energy Analysis get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

uCT ATLAS with uWS-CT-Dual Energy Analysis

K203448 · Shanghai United Imaging Healthcare Co., Ltd. · JAK · Aug 11, 2021 · Radiology

Device Facts

Record ID	K203448
Device Name	uCT ATLAS with uWS-CT-Dual Energy Analysis
Applicant	Shanghai United Imaging Healthcare Co., Ltd.
Product Code	JAK · Radiology
Decision Date	Aug 11, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML

Intended Use

uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography. uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc. uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. uWS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

Device Story

Multi-slice CT scanner; 320-row detector; 160mm z-coverage; 0.25s rotation speed. Inputs: X-ray transmission data at various angles/planes; dual-energy data via different tube voltages/currents. Processing: Deep IR (AIIR) reconstruction combining model-based iterative reconstruction and deep learning to reduce noise/artifacts; uAI Vision for patient positioning; deep learning-based organ recognition for dose modulation (Auto ALARA) and scan range (EasyRange); CardioCapture for coronary artery extraction. Outputs: Cross-sectional images; dual-energy material decomposition (e.g., water-iodine, uric acid-calcium). Used in clinical settings by trained operators. Output aids clinicians in diagnosis, lung cancer screening, and tissue characterization. Benefits: Reduced radiation dose, improved low-contrast detectability, and fast volumetric scanning for cardiac/vascular applications.

Clinical Evidence

No clinical study included. Substantial equivalence supported by non-clinical bench testing, including dosimetry, image performance tests, and software verification/validation.

Technological Characteristics

320-row 0.5mm-slice detector; 82cm bore; 0.25s rotation speed. Reconstruction: Deep IR (AIIR) combining model-based iterative reconstruction and deep learning. Connectivity: DICOM compliant. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-2-44, NEMA XR 25/28/29, ISO 10993.

Indications for Use

Indicated for head, whole body, cardiac, and vascular CT imaging. Includes low-dose lung cancer screening for early detection of lung nodules in patients meeting established governmental or professional society protocols.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

uCT 760, uCT 780 (K172135)

Reference Devices

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 (K161009)
Deep Recon (K193073)
DUAL ENERGY SYSTEM PACKAGE (K132813)
DISCOVERY CT750 HD (K120833)

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Submission Summary (Full Text)

{0}------------------------------------------------ August 11, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font. Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No. 2258 Chengei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA ## Re: K203448 Trade/Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 12, 2021 Received: July 15, 2021 ### Dear Xin Gao: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, . for Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203448 Device Name uCT ATLAS with uWS-CT-Dual Energy Analysis #### Indications for Use (Describe) uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography. uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc. uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. u WS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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. # 510 (K) SUMMARY ### K203448 - 1. Date of Preparation November 18, 2020 #### Sponsor Identification 2. # Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Contact Person: Xin GAO Position: RA Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com #### 3. Identification of Proposed Device Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Common Name: Computed Tomography X-ray System Model(s): uCT ATLAS ### Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology #### 4. Identification of Predicate/Reference Device(s) Predicate Device 510(k) Number: K172135 Device Name: uCT 760, uCT 780 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology ### Reference Device #1 510(k) Number: K161009 Device Name: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray and has a white vertical line running through the center, creating a negative space effect. Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Reference Device #2 510(k) Number: K193073 Device Name: Deep Recon Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Reference Device #3 510(k) Number: K132813 Device Name: DUAL ENERGY SYSTEM PACKAGE Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Reference Device #4 510(k) Number: K120833 Device Name: DISCOVERY CT750 HD Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK #### ട്. Device Description: The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories. The uCT ATLAS is a multi-slice computed tomography scanner that features the following specification and technologies. - 160 mm z-coverage in a single axial exposure with a 320-row 0.5 mm-slice Z-• Detector - . 0.25 s rotation speed for high temporal resolution, and maximum 440 mm/s fast volumetric scanning capability - . 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible positioning and access for all patients - . The new generation reconstruction method. Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern, and the colors are muted. improving low contrast detectability and spatial resolution - . The uAI Vision patient positioning assistance Built upon these technologies, the uCT ATLAS is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the whole organ coverage and fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging. The uWS-CT-Dual Energy Analysis is a software package that uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information. # 6. Indications for Use The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes a CT System and a software package. uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography. uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc. uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical societv. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. uWS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in bold. The color of the text and the "U" shape is a dark teal. Analysis software combines images acquired with low and high energy spectra to visualize this information. #### 7. Comparison of Technological Characteristics with the Predicate/Reference Devices The uCT ATLAS with uWS-CT-Dual Energy Analysis has the same intended use as the predicate device uCT 760, uCT 780. The proposed device includes more technology/features, which is discussed in the following chapters, than the predicate device. These differences will not impact the safety and effectiveness of the device. | ITEM | Proposed Device | Predicate Device uCT 760, uCT 780 (K172135) | Remark | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Specifications | | | | | Gantry | ● 160mm Detector Rotation speed: up to 0.25s/rotation ● 82cm bore | ● 40mm Detector Rotation speed: up to 0.35s/rotation (uCT 760); up to 0.3s/rotation (uCT 780) ● 70cm bore | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | Patient Table | Max. load capacity 318kg | Max. load capacity 205kg | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | Reconstruction Field of View | 40mm-500mm 40mm-600mm with extend FOV | 40mm-500mm | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | Maximum slices generated per rotation | 640 | uCT 760:128 uCT 780:160 | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | Functions | | | | | Low Dose CT Lung Cancer Screening Protocol | Yes | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | uAI Vision - EasyPositioning EasyISO | Yes, | -- | Substantially Equivalent | | | It's a patient positioning assistance function based on deep learning technology | -- | The changes did not raise new safety and effectiveness concerns. | | Auto ALARA kVp | Yes It can recommend the suitable kVp for the examination. | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | Organ-Based Auto ALARA mA | Yes It can optimize the dose modulation for the combined chest and abdomen scan with deep learning based organ recognition. | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | CardioXphase | Yes It can recommend the optimal phase for cardiac reconstruction with less motion artifact. | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | CardioCapture | Yes It can reduce the coronary motion artifact with deep learning based coronary artery extraction. | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | EasyRange | Yes It can automatically recommend the scan range with a deep learning organ recognition technology | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | Injector Linkage | Yes | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | | Remote Assistance | Yes | -- | Substantially Equivalent The changes did not raise new safety and effectiveness concerns. | ## Table 1 Comparisons to Predicate Device {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue and has a white vertical line running through the center. The logo is simple and modern in design. | Item | Proposed device | Reference device #1 Aquilion ONE Vision With FIRST 2.0 (CCRS-001B) V7.4 (K161009) | Reference device #2 Deep Recon (K193073) | Discussion of differences | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Anatomical Region | Abdomen, pelvis, chest | Abdomen, pelvis, chest, cardiac and extremities | Abdomen, pelvis, chest, cardiac and head | Same | | Exposure Dose Reduction | Yes | Yes | Yes | Same | | Quantitative Dose Reduction Claim | Yes | Yes | Yes | Same | | Image Quality Improvement Claim | Yes | Yes | Yes | Same | | Reconstruction Technology | It is an image reconstruction method that combines a modal-based iterative reconstruction and deep learning technology. | It is an iterative reconstruction algorithm. | Dedicated deep neural network (DNN) which is trained on low dose FBP images to get normal dose (high quality) FBP images | Substantially Equivalent Testing did not raise new safety and effectiveness concerns. | ## Table 3 Dual Energy comparison to Reference Devices | Item | Proposed Device | Reference device #3 Dual Energy System Package (K132813) | Reference device #4 Discovery CT750 HD (K120833) | Discussion of differences | |-----------------------------------------|--------------------|----------------------------------------------------------------|--------------------------------------------------------|------------------------------| | Dual Energy Scan | Yes | Yes | Yes | Same | | Dual Energy Analysis | | | | | | Mono Energetic Image | Yes | Yes | -- | Same | | Mixed Enhanced Image | Yes | Yes | -- | Same | | CNR(Contrast Noise Ratio) Image | Yes | Yes | -- | Same | | Water-Iodine Base Material Pair | Yes | -- | Yes | Same | | Water-Calcium Base Material Pair | Yes | -- | Yes | Same | | Calcium-Iodine Base Material Pair | Yes | -- | Yes | Same | | Uric acid-Calcium Base Material Pair | Yes | -- | Yes | Same | | Image Registration | Yes | Yes | -- | Same | | Effective Atomic Number Images | Yes | -- | Yes | Same | | Electron Density Image | Yes | -- | Yes | Same | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray. The logo is simple and modern in design. | Virtual Non contrast Images | Yes | -- | Yes | Same | |----------------------------------------------------------------------------------------|-----|-----|-----|------| | Component analysis of kidney stones, uric acid stones or non-uric acid stones | Yes | Yes | -- | Same | | Component analysis of joint gout, uric acid gout or non- uric acid gout | Yes | Yes | -- | Same | #### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. # Non-Clinical Testing Non-clinical testing including dosimetry and image performance tests were conducted for the uCT ATLAS with uWS-CT Dual Energy Analysis during the product development. UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance: # Electrical Safety and Electromagnetic Compatibility (EMC) Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uCT 760/780 in accordance with the following standards: - A ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - A IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography - > IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsIEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008). Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] # Product Particular Standards - NEMA XR 25-2019, Computed Tomography Dose Check A - A NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT - > NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management - > IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment - Part 1-3: {10}------------------------------------------------ Image /page/10/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 with a white vertical line running through the center. General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-ray Equipment - A IEC 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)] ## Performance Verification - A Performance Evaluation Report for the functions - A Clinical Image Evaluation of applications ## Software - NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine A (DICOM) - A IEC 62304: Medical Device Software - software life cycle process - > Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - > Content of Premarket Submissions for Management of Cybersecurity in Medical Devices # Biocompatibility - ISO 10993-5 Third Edition 2009-06-01. Biological Evaluation Of Medical > Devices - Part 5: Tests For In Vitro Cytotoxicity - A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization # Other Standards and Guidances - A ISO 14971: Medical Devices - Application of risk management to medical devices - Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A - > Code of Federal Regulations, Title 21, Subchapter J - Radiological Health - A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50) - > Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography # Software Verification and Validation Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission. The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have {11}------------------------------------------------ Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is divided vertically into two halves, with a horizontal line connecting the two halves in the upper portion of the "U". The logo is simple and modern in design. met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence. UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission. ## Clinical Testing No Clinical Study is included in this submission. ## Summarv The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT ATLAS with uWS-CT Dual Energy Analysis was found to have a safety and effectiveness profile that is similar to the predicate device. #### 9. Conclusions Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety, and effetiveness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety, and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.