Who is the manufacturer of Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

Canon Medical Systems, USA filed the 510(k) submission for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A (K182223).

What is the FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

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 ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

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

What are the predicate devices for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT (K143223); Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 (K170177); Alphenix, INFX-8000C/B, V8.0 (K181804).

Who can help prepare an FDA 510(k) submission like Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

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.

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A

K182223 · Canon Medical Systems, USA · JAK · Sep 14, 2018 · Radiology

Device Facts

Record ID	K182223
Device Name	Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
Applicant	Canon Medical Systems, USA
Product Code	JAK · Radiology
Decision Date	Sep 14, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2

Intended Use

Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis). Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.

Device Story

Optional movable gantry base kit for Aquilion ONE CT systems; enables longitudinal gantry movement along floor rails; allows z-axis image acquisition (axial/helical) when using fixed catheterization table from INFX-8000C interventional x-ray system. Used in clinical interventional radiology suites; operated by radiology staff. System interlocks prevent interference between CT and interventional x-ray systems in shared room. Output consists of CT images acquired during longitudinal gantry travel; assists clinicians in interventional procedure guidance. Benefits include improved workflow and patient access during combined CT/interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Verification/validation testing confirmed base movement speed, stop position accuracy, scanogram/axial/helical scan functions, and safety interlocks (contact detection, emergency stop, slide running) met specifications.

Technological Characteristics

Movable gantry base unit; floor-mounted rail system; gantry tilt max +/-28°; scan speed 90-110 mm/s; scan range up to 1800 mm. Conforms to IEC 60601-1, 60601-1-2, 60601-2-44, and NEMA XR-25/26. Integrates with Aquilion ONE CT and INFX-8000C interventional systems via hardware interlocks. Software documentation provided for Moderate Level of Concern.

Indications for Use

Indicated for use with Aquilion ONE (TSX-305A) CT systems to enable longitudinal gantry movement and z-axis image acquisition in an interventional radiology (IVR-CT) environment using a fixed catheterization table.

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

CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT (K143223)
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 (K170177)
Alphenix, INFX-8000C/B, V8.0 (K181804)

Related Devices

K134025 — AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT · Toshibamedical Systems Corporation · Sep 5, 2014
K143223 — CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT · Toshibamedical Systems Corporation · Jan 12, 2015
K111633 — AQUILION LB MOVEMENT BASE KIT · Toshiba America Medical Systems, In.C · Aug 25, 2011
K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP · Canon Medical Systems Corporation · Sep 26, 2025
K091673 — GE LIGHTSPEED ACT FP16 · Ge Medical Systems, Inc. · Jun 24, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 14, 2018 Canon Medical Systems USA Orlando Tadeo Sr. Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN, CA 92780 Re: K182223 Trade/Device Name: Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 15, 2018 Received: August 16, 2018 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Hole 2. Nils Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182223 Device Name Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A #### Indications for Use (Describe) Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis). Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room. Type of Use (Select one or both, as applicable) | <div> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M0 2a2 2 0 0 1 2-2h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2zm1.5 0a.5.5 0 0 0-.5.5v12a.5.5 0 0 0 .5.5h12a.5.5 0 0 0 .5-.5V2.5a.5.5 0 0 0-.5-.5H1.5z" fill-rule="evenodd"></path> </svg> 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}------------------------------------------------ # 510(k) SUMMARY - SUBMITTER'S NAME: 1. Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550 - 2. OFFICIAL CORRESPONDENT Naofumi Watanabe - 3. ESTABLISHMENT REGISTRATION: 9614698 #### 4. CONTACT PERSON: Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 otadeo@us.medical.canon (714) 669-7459 - 5. Date Prepared: August 15, 2018 - 6. TRADE NAME(S): Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A #### COMMON NAME: 7. Computed Tomography X-Ray System #### 8. DEVICE CLASSIFICATION: Regulatory Class: II Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System 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 | |----------------------------------------------------------------------------|------------------------------------|----------------------|-------------------------------------------------------|-----------------|------------------|------------------| | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Canon Medical Systems USA | 21 CFR 892.1750 | Computed Tomography System | JAK | K143223 | January 12, 2015 | | Aquilion ONE (TSX- 305A/3) V8.3 with FIRST 2.1 | Canon Medical Systems USA | 21 CFR 892.1750 | Computed Tomography System | JAK | K170177 | June 30, 2017 | | Alphenix, INFX- 8000C/B, V8.0 | Canon Medical Systems USA | 21 CFR 892.1650 | Image- intensified fluoroscopic x-ray system | OWB | K181804 | August 2, 2018 | #### 11. REASON FOR SUBMISSION: Modification of a cleared device. The purpose of this submission is to seek market clearance for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A. # 12. DEVICE DESCRIPTION: The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-305A/3. This combination enables patient access and efficient workflow for interventional procedures. Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, INFX-8000C. The Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses and technological characteristics of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems. Please note: The terms "Self-Propelled Scan Base", "Moving Base" and "Movement Base" are used interchangeably throughout this submission. They all refer to the same unit. {5}------------------------------------------------ ## 13. INDICATIONS FOR USE: Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis). Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room. ### 14. SUBSTANTIAL EQUIVALENCE: This device is substantially equivalent to CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT, which received premarket clearance under K143223, marketed by Canon Medical Systems USA. Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, incorporates modifications to the cleared device in order for the self-propelled scan base unit to be connected to an Aquilion One CT gantry. This allows the CT system to acquire images in the z-direction (Z-axis) when a fixed catheterization table is used for patient support instead of a dedicated CT patient couch. The indications for use, method of operation including the imaging chain, base software and manufacturing process of the CT and Interventional XR systems remain unchanged from the cleared devices. | Item | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Comments | |------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------|-----------------------| | CT System | Aquilion ONE (K170177) | Aquilion PRIME (K141741) | Changed | | X-Ray System | INFX-8000C (V8.2 Software) (K181804) | INFX-8000C (V6.01 Software) (K113052) | Changed | | Gantry drive | Movement along rails laid on the floor | Movement along rails laid on the floor | Same | | Cabling | Floor cabling | Floor cabling | Same | | Digging depth of the floor | Approximately 130 mm | Approximately 152 mm | Reduced digging depth | | Couch | Fixed catheterization table (INFX-8000C System) | Fixed catheterization table (INFX-8000C System) | Same | | Scan direction | IN/OUT directions | IN/OUT directions | Same | | Direction of Scanogram acquisition | IN/OUT directions | IN/OUT directions | Same | | Gantry Tilt | Max. +/-28° | Max. +/-30° | Changed | See below for a brief summary of changes from Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A: {6}------------------------------------------------ | Item | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A | CGBA-032A, Aquilion PRIME Self- Propelled Scan Base Kit for IVR-CT | Comments | |------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------| | Scanoscopy speed | 90 - 110 mm/s (Remote access Possible from the console except Table Up/Down operation) | 100 mm/s | Changed | | Scan field in the longitudinal direction | Scanoscopy: Adjustable from 200 mm to 1800 mm Helical scan: Max. 1800 mm/scan | Scanoscopy: Adjustable from 200 mm to 1390 mm Helical scan: Max. 1390 mm/scan | Changed | # 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 IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, IEC 60825, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020. ### 16. TESTING This submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met. Evaluation of the modified device included, but was not limited to, confirmation that base movement speed, stop position accuracy, scanogram and axial/helical scan functions, and interlocks including contact detection, emergency stop and slide running performed according to specifications. 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 also included as part of this submission. Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems. #### 17. CONCLUSION The Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is substantially equivalent to the predicate device. The subject device function in a manner similar to and is intended for the same use as the predicate device, as described in the labeling. Based upon the bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.