Who is the manufacturer of Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i?

Canon Medical Systems Corporation filed the 510(k) submission for Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (K222819).

What is the FDA product code for Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i?

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

What is the regulatory pathway for Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i?

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

Does Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i use AI or machine learning?

Yes. Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (K222819) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i?

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i (K201836); Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i (K192832).

Who can help prepare an FDA 510(k) submission like Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i?

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 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i 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.

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

K222819 · Canon Medical Systems Corporation · JAK · Mar 3, 2023 · Radiology

Device Facts

Record ID	K222819
Device Name	Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Applicant	Canon Medical Systems Corporation
Product Code	JAK · Radiology
Decision Date	Mar 3, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Noise reduction	Deep Convolutional Neural Network	—	—	—	—	Clinical image review of body, cardiac, chest, head, and extremity diagnostic images	1 (American Board-Certified Radiologist)

Indications for Use

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve has the capability to provide volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

Device Story

Whole-body multi-slice helical CT scanner; includes gantry, couch, console. Captures cross-sectional volume data; processes/displays images. Operated by trained physicians in clinical settings. Features AiCE (Deep Convolutional Neural Network) for noise reduction; AIDR 3D for iterative dose reduction. Includes automated scan planning, 3D landmark scanning, and Flex e-Tilt. Output viewed by radiologists for diagnostic assessment; aids clinical decision-making by providing high-quality, low-noise images for various anatomical applications (abdomen, pelvis, lung, cardiac, head, etc.).

Clinical Evidence

Bench testing only. Evaluated image quality metrics (CNR, CT number accuracy, uniformity, SSP, MTF, SD, NPS, LCD) across various modes (body, lung, cardiac, etc.). Phantom studies confirmed 3D scano water equivalence and improved LCD/noise reduction compared to AIDR. Clinical image quality confirmed by American Board-Certified Radiologist review. No prospective clinical trials reported.

Technological Characteristics

Multi-slice helical CT scanner. Components: gantry, couch, console. Materials: standard medical-grade components per ISO 13485. Energy: Ionizing radiation (21 CFR 1020). Connectivity: Networked console. Software: Deep Convolutional Neural Network (AiCE) and iterative reconstruction (AIDR 3D). Standards: IEC 60601-1, 60601-1-3, 60601-2-44, NEMA XR-26/29.

Indications for Use

Indicated for whole-body, including head, cross-sectional volume acquisition and display in patients requiring specialized CT studies. Used by trained, qualified physicians.

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

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i (K201836)
Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i (K192832)

Reference Devices

Aquilion ONE / GENESIS Edition (cited for lung cancer screening protocol comparison)
TSX-306A (K213504)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission. March 3, 2023 Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780 Re: K222819 Trade/Device Name: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: February 1, 2023 Received: February 2, 2023 Dear Orlando Tadeo: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222819 Device Name Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i ### Indications for Use (Describe) This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve has the capability to provide volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications. | 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 shows the logo for Canon Medical Systems USA, INC. The word "Canon" is in red, and the rest of the text is in black. The text is left-aligned and the font is sans-serif. The logo is simple and professional. # 510(k) SUMMARY 1. SUBMITTER'S NAME: Fumiaki Teshima Senior Manager, Quality Assurance Department Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550 - 2. ESTABLISHMENT REGISTRATION: 9614698 #### 3. OFFICIAL CORRESPONDENT/CONTACT PERSON: Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459 - 4. DATE PREPARED: September 16, 2022 - 5. TRADE NAME(S): Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i #### COMMON NAME: 6. Computed Tomography X-ray System #### 7. DEVICE CLASSIFICATION: a) Classification Name: Computed Tomography X-ray system b) Regulation Number: 21 CFR §892.1750 c) Regulatory Class: Class II #### 8. PRODUCT CODE: JAK #### 9. PERFORMANCE STANDARD: This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780 {4}------------------------------------------------ #### 10. PREDICATE DEVICE: | Product | Marketed by | Regulation Number | Regulation Name | Product Code | 510(k) Number | Clearance Date | |--------------------------------------------------------------------------------|----------------------------------|---------------------|----------------------------------------|---------------------------------------------------|---------------|----------------| | Primary Predicate: Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems, USA | 21 CFR §892.1750 | Computed Tomography X-ray System | JAK: System, X-ray, Tomography, Computed | K201836 | 01/12/2021 | | Reference Predicate: Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i | Canon Medical Systems, USA | 21 CFR §892.1750 | Computed Tomography X-ray System | JAK: System, X-ray, Tomography, Computed | K192832 | 02/21/2020 | #### 11. REASON FOR SUBMISSION: New medical device #### 12. DEVICE DESCRIPTION: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (Advanced intelligent Clear-IQ Engine-integrated) is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems. #### 13. INDICATIONS FOR USE: This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software, by a trained and qualified physician. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications. #### 14. SUBSTANTIAL EQUIVALENCE: The Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is substantially equivalent to Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i, which received premarket clearance under K201836, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion Serve is the same as that of the predicate device. A comparison of the technological characteristics between the subject and the predicate device is included below. | | Subject Device | Predicate Device | Comment | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name, Model Number | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | | | 510(k) Number | This submission | K201836 | | | Scan modes | Conventional scan (Axial Scan*) Volume, Dynamic volume scan Helical scan | Conventional scan (S&S, S&V) Volume, Dynamic volume scan Helical scan | *: S&V is not supported S&S is called "Axial Scan" | | | Subject Device | Predicate Device | Comment | | Device Name, Model Number | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | | | 510(k) Number | This submission | K201836 | | | Positioning Scan | Positioning: Single | Scanoscopy: Scano | | | | Dual 3D Landmark Scan | Dual Scano | | | 3D Landmark Scan | Available | Not Available | | | Anatomical Landmark Detection | Available | Not Available | | | Scan planning assist function* | Available | Not Available | *: If 3D Landmark Scan is set in a scan protocol. | | Scan slice thickness | [Conventional scan (Axial scan)] 4-row scan: 0.5, 1, 2, 3, 4, 5, 8 mm 1-row scan: 1 mm [Volume, Dynamic volume scan] (80-row scan*: 0.5 mm) 40-row scan: 0.5 mm [Helical scan] (80-row scan*: 0.5 mm) 40-row scan: 0.5 mm and 1 mm 20-row scan: 0.5 mm 4-row scan: 0.5 mm [3D Landmark Scan] 40-row scan: 1.0 mm | [Conventional scan (S&S, S&V)] 4-row scan: 0.5, 1, 2, 3, 4, 5, 8, 10 mm 1-row scan: 1 mm [Volume, Dynamic volume scan] (80-row scan*: 0.5 mm) 40-row scan: 0.5 mm and 1 mm 4-row scan: 8 mm and 10 mm [Helical scan] (80-row scan*: 0.5 mm) 40-row scan: 0.5 mm and 1 mm 20-row scan: 0.5 mm and 1 mm 4-row scan: 0.5 mm | scan protocol. *: Option | | Image reconstruction time | Up to 30 images/s with AIDR 3D (0.033 s/image) Up to 50 images/s with AIDR 3D (0.02 s/image)*1 Up to 70 images/s with AIDR 3D (0.014 s/image)*2 Up to 100 images/s with AIDR 3D (0.01 s/image) *3 (Depending on the scan and reconstruction conditions) | Up to 20 images/s with AIDR 3D (0.05 s/image) Up to 50 images/s with AIDR 3D (0.02 s/image) *2 (Depending on the scan and reconstruction conditions) | *1: When the Fast scan kit (CGS- 041A) is installed. *2: Option When the Fast Image Reconstruction kit (CCFR-010A) is installed. *3: When the Fast Image Reconstruction kit (CCFR-010A) and the Fast scan kit (CGS-041A) are installed. | | Flex e-Tilt | Available | Not Available | | | | Subject Device | Predicate Device | Comment | | Device Name, Model Number | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | | | 510(k) Number | This submission | K201836 | | | Gantry opening diameter (aperture) | 800 mm in diameter | 780 mm in diameter | | | Wedge filter types | Three (3) types - Small - Large - SilverBeam Filter* | Two (2) types - Small - Large | *Previously cleared under K213504 (TSX-306A) | | Gantry internal cameras | Available | Not Available | Two cameras mounted inside the system at a 90-degree phase difference. | | Reconstruction functions | Identified as anatomical regions* | Identified as numbered functions | *Previously cleared under K213504 (TSX-306A) | | Noise reduction processing | Adaptive Iterative Dose Reduction 3D (AIDR 3D) | Adaptive Iterative Dose Reduction 3D (AIDR 3D) | | | | AIDR 3D Enhanced | AIDR 3D Enhanced | | | | Advanced Intelligent Clear-IQ Engine (AiCE) | Advanced Intelligent Clear-IQ Engine (AiCE) | | | | | Quantum Denoising Software (QDS) | | | NewUX Console* | Available | Not Available | *Previously cleared under K213504 (TSX-306A) | | Display monitor | 27 inch (3840 x 2160) | 19 inch (1280 x 1024) | | | User Input | Keyboard and Control Pad (Performs scan operation and controls voice messages) | Scan Keyboard | | | Data processor | CPU : 64-bit Memory size: 64 Gbyte or more | CPU : 64-bit Memory size: 32 Gbyte or more | | | Window width/level | Controlled and continuously variable using the mouse | Controlled and continuously variable using a speed-sensitive rotary encoder | | | Preset windows | 1/image | 3/image | | | Window types | Linear only | Linear and non-linear (6 user- programmable), and double windows | | | ROI shape available | Point, Circular | Point, square, free-form, circular, polygon | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### 15. SAFETY: The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the following standards IEC60601-1, IEC60601-1-3, IEC60601-1-6, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA XR-26 and NEMA XR-29. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020. This device conforms to applicable Performance Standards for lonizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] #### 16. TESTING Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met. # Performance Testing - Bench ## Objective IQ Performance Comparison An image quality metric evaluation comparing performance of the TSX-307A (Aquillon Serve) system relative to the predicate device was conducted. In order to compare the image quality between these two systems, the following image quality performance tests were conducted. It was concluded that the subject device demonstrated equivalent or improved performance, compared to the predicate device, as demonstrated by the results of the above testing. - 1. Contrast-to-Noise Ratios (CNR) - 2. CT Number Accuracy - 3. Uniformity - Slice Sensitivity Profile (SSP) 4. - 5. Modulation Transfer Function (MTF)-Wire - 6. Standard Deviation of Noise (SD) - 7. Noise Power Spectra (NPS) - 8. Low Contrast Detectability (LCD) # Image Quality Metric Evaluation An image quality metric evaluation of Aquilion Serve (TSX-307A/1) V1.2 reconstructed with AiCE, for the available Body, Body Sharp, Lung, Bone, Inner ear, Brain LCD, Brain CTA and Cardiac modes was conducted and equivalent or improved image quality performance relative to FBP and AIDR 3D was demonstrated. The following image quality performance tests were conducted: Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Wire, Modulation Transfer Function (MTF)-Edge, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), Low Contrast Detectability (LCD), Pediatric. AiCE Reconstruction for Lung Cancer Screening Image Quality Metric Evaluation The performance of the subject device (Aquilion Serve with AiCE) was compared to the results for the Aquilion ONE / GENESIS Edition with the AAPM lung cancer screening protocol for both a small and a larger sized phantom. Please note the AAPM protocol {8}------------------------------------------------ does not use a fixed mA, but rather an automatic exposure setting of 20HU. Therefore, the dose for the predicate device was determined by first establishing the AECpredicated dose for each phantom and then scanning with a fixed technique on the GENESIS based on the result. The nearest fixed technique on the Serve was then scanned. All results were reconstructed with AIDR (FC18 and FC52) as prescribed by the AAPM protocol and were also reconstructed with AiCE DLR Body Sharp and AiCE Lung and FBP FC18. In order to compare the image quality between AiCE DLR on the Aquilion Serve and Aquilion ONE / GENESIS Edition with AIDR (AAPM protocol), the following image quality performance tests were conducted: - Contrast-to-Noise Ratios (CNR) 1. - 2. CT Number Accuracy - ന് Uniformity - 4. Slice Sensitivity Profile (SSP) - 5. Modulation Transfer Function (MTF)-Edge - 6. Standard Deviation of Noise (SD) - 7. Noise Power Spectra (NPS) It was concluded that the subject device demonstrated equivalent or improved performance as demonstrated by the results of the above testing. ### Automatic Scan Planning Volunteer assessment demonstrated that couch movement appropriately positioned volunteers to the selected anatomical region. ### Flex e-Tilt Image comparison studies were conducted between Flex e-Tilt reconstructed images with the Aquilion Serve versus conventional tilt and MPR (oblique) images utilizing the predicate device, Aquilion Lightning. It was determined that the images were equivalent and there were no significant differences observed. ### Noise Texture An analysis of the NPS and kurtosis values for FBP, FIRST and AiCE was conducted and the results of the study support the following claims, more natural noise texture compared to FIRST, noise texture as natural as filtered backprojection, and noise texture distinct from MBIR. ### Quantitative Spatial Resolution A comparison study was conducted, utilizing phantoms, in order to support a quantitative spatial resolution improvement claim of twice the high contrast spatial resolution for AiCE Body at 10% MTF and a 4.1 lp/cm increase in high contrast spatial resolution for AiCE Cardiac at 10% MTF as compared to AIDR reconstruction. ### Quantitative Body LCD and Noise Improvement and Dose Reduction A phantom study was conducted using the MITA - FDA LCD Body phantom and the results demonstrated improved low contrast detectability at the same dose for AiCE body compared to AIDR, noise reduction with AiCE at the same dose for body compared to AIDR and dose reduction for AiCE Abdomen relative to FBP. {9}------------------------------------------------ # 3D Scano Water Equivalence A comparison phantom study was conducted utilizing a 24cm and 32cm water phantom to demonstrate that both 3D Scano and dual scano produced 24cm and 32cm water equivalent diameters with less than 5% mean absolute error. # Low Contrast Detectability Evaluation A phantom study was conducted in order to support claims of low-contrast detectability of 8.8 mGy (0.3%/3 mm) of AIDR3D, and 15.9mGv (0.3% / 2mm) and 8.1mGv (0.3% / 3mm) of AiCE, respectively. # Performance Testing – Clinical Images Representative body, cardiac, chest, head, and extremity diagnostic images, reviewed by an American Board-Certified Radiologist, were obtained using the subject device and it was confirmed that the reconstructed images using the subject device were of diagnostic quality. A summary of the risk analysis and verification/validation testing conducted through bench and clinical testing is included in this submission which demonstrates that the requirements for the system have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is included in this submission. This documentation includes justification for the Moderate Level of Concern determination as well as testing which demonstrates that the verification and validation requirements for the modifications described above have been met. A Software Information Checklist is included at the conclusion of this Executive Summary. Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices " issued on October 2, 2014, is also included as part of this submission. #### 17. CONCLUSION The Aquilion Serve (TSX-307A/1) V1.2 with AiCE performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device has demonstrated substantial equivalence to the predicate device and is safe and effective for its intended use.

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

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Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

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