(232 days)
TSX-304A/4
No.
The document does not mention the presence of AI, DNN, or ML models within the device itself. While it mentions a predicate device that includes "AiCE" (which typically stands for Advanced intelligent Clear-IQ Engine and implies AI), this specific device (TSX-501R/1 V11.1) does not explicitly state it contains an AI model. The text focuses on the X-ray detector unit, image reconstruction capabilities, and performance metrics, none of which indicate AI model incorporation for its primary function of acquiring and displaying cross-sectional volumes.
No
This device is a CT scanner, which is used for diagnostic imaging (acquiring and displaying cross-sectional volumes) and not for treating or rehabilitating patients.
Yes
The device explicitly states its purpose is to "acquire and display cross-sectional volumes" and that these "volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician," and further that "reconstructed images using the subject device were of diagnostic quality," all of which point to its intended use in making a diagnosis.
No
The device is a CT scanner, which is a hardware medical device that acquires images using X-rays. While it involves software for image reconstruction and processing ("Reconstruction matrix – CT images: 512 x 512..."), it is fundamentally a hardware system ("CT Scanner TSX-501R/1 V11.1 employs a next-generation X-ray detector unit..."). The 510(k) summary explicitly details hardware components, bench testing on physical properties, and image acquisition, which are not characteristics of a software-only medical device.
No.
This device is a CT scanner for imaging the human body, not for testing samples derived from the human body.
N/A
Intended Use / Indications for Use
This device is indicated to acquire and display cross-sectional volumes of the whole body (abdomen, pelvis, chest, extremities, and head) of adult patients.
TSX-501R has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Product codes
JAK
Device Description
CT Scanner TSX-501R/1 V11.1 employs a next-generation X-ray detector unit (photon counting detector unit), which allows images to be obtained based on X-rays with different energy levels. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
whole body (abdomen, pelvis, chest, extremities, and head)
Indicated Patient Age Range
adult patients. / Adults only
Intended User / Care Setting
trained and qualified physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance Testing - Bench
Image Quality Evaluations
CT image quality assessments were performed, utilizing phantoms, to evaluate the Objective Image Quality Performance of the CT Scanner TSX-501R/1 V11.1 system relative to the predicate device, Aquilion Precision (TSX-304A/4) V10.14 with AiCE, with regard to Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity and Pulse Pile Up, Slice Sensitivity Profile (SSPz), Modulation Transfer Function (MTF), Standard Deviation of Noise and Pulse Pile, Noise Power Spectra (NPS), and Low Contrast Detectability (LCD). 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.
Fundamental Properties of the Photon Counting Detector
A comprehensive assessment of the fundamental properties of the Photon Counting Detector was also conducted in order to demonstrate the effectiveness of the CT Scanner TSX-501R/1 V11.1 system with respect to Detector resolution and noise properties (MTF and DQE), Artifact analysis, Count rate vs. current curve, Pulse pileup or maximum count rate, Lag/residual signal levels, Stability over time, and Bad pixel map. These bench studies utilized phantom data and achieved results demonstrative of equivalent performance in comparison with the predicate device.
Performance Testing – Clinical Images
Representative chest, abdomen, brain and MSK diagnostic images, reviewed by American Board-Certified Radiologists, were obtained using the subject device and it was confirmed that the reconstructed images using the subject device were of diagnostic quality.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 20, 2025
Canon Medical Systems Corporation
℅ Orlando Tadeo
Director, Regulatory Affairs
Canon Medical Systems, USA
2441 Michelle Drive
TUSTIN, CA 92780
Re: K243398
Trade/Device Name: CT Scanner TSX-501R/1 V11.1
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: JAK
Dated: May 14, 2025
Received: May 14, 2025
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 (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.
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K243398 - Orlando Tadeo Page 2
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).
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 (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-reporting-combination-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243398 - Orlando Tadeo Page 3
assistance/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,
Digitally signed by Gabriela M. Rodal -S for
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
| Submission Number (if known) |
|---|
| K243398 |
| Device Name |
|---|
| CT Scanner TSX-501R/1 V11.1 |
Indications for Use (Describe)
This device is indicated to acquire and display cross-sectional volumes of the whole body (abdomen, pelvis, chest, extremities, and head) of adult patients.
TSX-501R has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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."
Page 5
Page 1 of 4
2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968
https://us.medical.canon
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.
Director, Regulatory Affairs
Canon Medical Systems USA, Inc
2441 Michelle Drive
Tustin, CA 92780
(714) 669-7459
4. DATE PREPARED:
October 31, 2024
5. TRADE NAME(S):
CT Scanner TSX-501R/1 V11.1
6. COMMON NAME:
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]
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Page 2 of 4
10. PREDICATE DEVICE:
| Product | Marketed by | Regulation Number | Regulation Name | Product Code | 510(k) Number | Clearance Date |
|---|---|---|---|---|---|---|
| Primary Predicate Device | ||||||
| Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems, USA | 21 CFR §892.1750 | Computed Tomography X-ray System | JAK: System, X-ray, Tomography, Computed | K223726 | March 7, 2023 |
| Reference Predicate Device | ||||||
| NAEOTOM Alpha, Scan&GO | Siemens Medical Solutions USA, Inc. | 21 CFR §892.1750 | Computed Tomography X-ray System | JAK: System, X-ray, Tomography, Computed | K211591 | September 30, 2021 |
11. REASON FOR SUBMISSION:
New medical device
DEVICE DESCRIPTION:
CT Scanner TSX-501R/1 V11.1 employs a next-generation X-ray detector unit (photon counting detector unit), which allows images to be obtained based on X-rays with different energy levels. 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.
12. INDICATIONS FOR USE:
This device is indicated to acquire and display cross-sectional volumes of the whole body (abdomen, pelvis, chest, extremities, and head) of adult patients.
TSX-501R has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
13. SUBSTANTIAL EQUIVALENCE:
The CT Scanner TSX-501R/1 V11.1 is substantially equivalent to Aquilion Precision (TSX-304A/4) V10.14 with AiCE, which received premarket clearance under K223726, and is marketed by Canon Medical Systems USA. The intended use of the CT Scanner TSX-501R/1 V11.1 is the same as that of the predicate device. The major difference between the subject device and the primary predicate device is that the CT Scanner TSX-501R incorporates a photon counting detector unit rather than the conventional Energy Integrating Detector (EID) utilized in the primary predicate device.
Other major software features and hardware components include those that have been 510(k) cleared under previous Canon pre-market submissions. A comparison of the technological characteristics between the subject and the predicate device is included below.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name, Model Number | CT Scanner TSX-501R/1 V11.1 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE |
| 510(k) Number | This submission | K223726 |
| Detector | Photon Counting Detector | Energy Integrating Detector (EID) |
| Intended patient population | Adults only | No known restrictions |
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| Subject Device | Predicate Device | |
|---|---|---|
| Device Name, Model Number | CT Scanner TSX-501R/1 V11.1 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE |
| 510(k) Number | This submission | K223726 |
| Scan modes | Conventional scan (S&S) | |
| Helical scan | ||
| Volume, Dynamic volume scan | Conventional scan (S&S, S&V) | |
| Helical scan | ||
| Volume, Dynamic volume scan | ||
| Configuration of the detector | 0.21 mm x 192 rows | 0.25 mm x 160 rows |
| Scan (Rotation) time | 0.35, 0.5, 0.75, 1.0 s | (0.23), 0.35, 0.375, 0.4, 0.45, 0.5, 0.6, 0.75, 1.0, 1.5, 2.0, 3.0 s |
| Scan slice thickness (Acquisition modes) | [Conventional scan (S&S)] | |
| 12 row scan: 0.21 mm | ||
| 4 row scan: 4.94 mm | ||
| [Volume, Dynamic volume scan] | ||
| 192 row scan: 0.21 mm | ||
| 96 row scan: 0.21 mm | ||
| 48 row scan: 0.21 mm | ||
| [Helical scan] | ||
| 192 row scan: 0.21 mm | ||
| 96 row scan: 0.21 mm | [Conventional scan (S&S, S&V)] | |
| 4 row scan: 0.25, 0.5, 1, 2, 3, 4, 5 mm | ||
| [Volume, Dynamic volume scan] | ||
| 160 row scan: 0.25 mm | ||
| 80 row scan: 0.25 and 0.5 mm | ||
| 40 row scan: 0.5 mm | ||
| [Helical scan] | ||
| 160 row scan: 0.25 mm | ||
| 80 row scan: 0.5 mm | ||
| 40 row scan: 0.5 mm | ||
| 4 row scan: 0.25 and 0.5 mm | ||
| Helical pitch | 30 to 288 | 2.5 to 224 |
| CT Pitch factor (Beam pitch) | 0.625 to 1.5 | 0.563 to 1.575 |
| Continuous scan time | Max. 50 s | Max. 100 s |
| Image reconstruction time | Up to 5 images/s (0.2 s/image) | |
| (depending on the scan and reconstruction conditions) | Up to 80 images/s (0.0125 s/image) | |
| (depending on the scan and reconstruction conditions) | ||
| Gantry tilt | N/A | ±30° |
| Maximum X-ray exposure permissible time (maximum) - 120 kV | 200 mA: 85 s | |
| 300 mA: 54.2 s | NR mode: | |
| 200 mA: 82 s, 300 mA: 52 s | ||
| HR mode: | ||
| 200 mA: 82 s, 300 mA: 52 s | ||
| SHR mode: | ||
| 200 mA: 82 s, 300 mA: 52 s | ||
| Reconstruction matrix – CT images: | 512 x 512 | |
| 1024 x 1024 | ||
| 1024 x 1024 x 384 | 512 x 512 | |
| 1024 x 1024 | ||
| 1024×1024×320 |
14. 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, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC81001-5-1, IEC62366-1, NEMA XR-25, 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.
15. TESTING
Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met.
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Performance Testing - Bench
Image Quality Evaluations
CT image quality assessments were performed, utilizing phantoms, to evaluate the Objective Image Quality Performance of the CT Scanner TSX-501R/1 V11.1 system relative to the predicate device, Aquilion Precision (TSX-304A/4) V10.14 with AiCE, with regard to Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity and Pulse Pile Up, Slice Sensitivity Profile (SSPz), Modulation Transfer Function (MTF), Standard Deviation of Noise and Pulse Pile, Noise Power Spectra (NPS), and Low Contrast Detectability (LCD). 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.
Fundamental Properties of the Photon Counting Detector
A comprehensive assessment of the fundamental properties of the Photon Counting Detector was also conducted in order to demonstrate the effectiveness of the CT Scanner TSX-501R/1 V11.1 system with respect to Detector resolution and noise properties (MTF and DQE), Artifact analysis, Count rate vs. current curve, Pulse pileup or maximum count rate, Lag/residual signal levels, Stability over time, and Bad pixel map. These bench studies utilized phantom data and achieved results demonstrative of equivalent performance in comparison with the predicate device.
Performance Testing – Clinical Images
Representative chest, abdomen, brain and MSK diagnostic images, reviewed by American Board-Certified Radiologists, 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 testing is included in this submission which demonstrates that the requirements for the system have been met.
Software Documentation for a Basic Documentation Level, per the FDA guidance document, "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is included in this submission. This documentation includes justification for the Basic Documentation Level determination as well as testing which demonstrates that the verification and validation requirements have been met.
Cybersecurity documentation, per the FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", issued on September 27, 2023, was included in this submission.
16. CONCLUSION
The CT Scanner TSX-501R/1 V11.1 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 as safe and effective for its intended use.