This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

Device Description

The Aquilion ONE Vision, TSX-301C/1, v4.90 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.

AI/ML Overview

The provided text is a 510(k) summary for the Toshiba Aquilion ONE Vision CT scanner. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new feature or algorithm. Therefore, many of the requested sections (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth details, training set size) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications. The "acceptance criteria" here are implicitly that the new device meets or exceeds the performance of the predicate device for critical technical specifications, which in turn supports the claim that the indications for use and safety/effectiveness remain unchanged.

Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria (Predicate Device K113466)	Reported Device Performance (Aquilion ONE Vision, TSX-301C/1)
Gantry Rotational Speed	0.35 Seconds	0.275 Seconds
View Rate (number of views transferred per second)	2572	2910
X-ray Generator Output Power	70kW Maximum	90kW Maximum
X-ray Tube angle	11 degrees	10 degrees
Computer System	Dual Core Xeon based	Quad Core Xeon based
Image reconstruction (maximum speed)	30 images per second	50 images per second
Gantry Opening	720mm	780mm

Summary of Changes:

Increased rotational speed from 350mS to 275mS.
X-ray Generator changed to match dose at new speed.
Tube has hardware enhancements to allow for higher rotational speed.
View rates have been increased.

Study Proving Device Meets Acceptance Criteria:

The submission does not describe a clinical study. Instead, it relies on technical testing and comparison to a predicate device to demonstrate substantial equivalence and adherence to safety standards.

17. TESTING: "Image Quality metrics utilizing phantoms are provided in 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."

This indicates that internal performance testing, likely using phantoms, was conducted to verify the changes and ensure image quality, and that the system conforms to relevant IEC standards for safety and performance. The specific details or results of these phantom tests are not included in this summary.

Additional Information Not Available in the Provided Text:

Sample size used for the test set and the data provenance: Not applicable, as no human subject test set or clinical study is described. The performance data is derived from technical specifications and phantom testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no human subject test set requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a CT scanner, not an AI-powered diagnostic tool requiring reader performance evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The submission focuses on hardware and core software modifications of a CT scanner, not on a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the "ground truth" for this submission are the technical specifications and performance of the predicate device, against which the modifications are compared.
The sample size for the training set: Not applicable, as this is a CT scanner modification, not an AI model training.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

K122109

Toshiba America Medical Systems, Inc.

510 (k) Premarket I Aquilion ONE Vision, TSX-301C/1, v4.90

510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

ご

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
1. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563

4. CONTACT PERSON:

Paul Biggins Director, Regulatory Affairs (714) 730-5000

1. Date Prepared: July 12, 2012
1. TRADE NAME(S): Aquilion ONE Vision, TSX-301C/1, v4.90
1. COMMON NAME: System, X-ray, Computed, Tomography
1. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
1. PRODUCT CODE / DESCRIPTION: JAK - System, Computed Tomography

10. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

1. PREDICATE DEVICE: Aquilion ONE TSX-301A/2, w/4.74ER K113466 Toshiba America Medical Systems, Inc.

12. REASON FOR SUBMISSION: Modification of a cleared device

SEP
21 2012

Page 1 of 3

{1}------------------------------------------------

13. DEVICE DESCRIPTION:

14. SUMMARY OF INTENDED USES:

15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aquilion ONE, TSX-301A/2, w4.74ER, K113466, marketed by Toshiba America Medical Systems. The Aquilion ONE Vision, TSX-301C/1. v4.90, includes modifications to the cleared device which improve the scan time and view rates. The method of operation, base software and manufacturing process remain unchanged from the cleared device.

ltem	Aquilion ONE Vision, TSX-301C/1	Aquilion ONE TSX-301A/2
Gantry Rotational Speed	0.275 Seconds	0.35 Seconds
View Rate(number of viewstransferred per second)	2910	2572
X-ray Generator OutputPower	90kW Maximum	70kW Maximum
X-ray Tube angle	10 degrees	11 degrees
Computer System	Quad Core Xeon based	Dual Core Xeon based
Image reconstruction(maximum speed)	50 images per second	30 images per second
Gantry Opening	780mm	720mm

Summary of Changes from Aquilion ONE TSX-301A/2

1. Increased rotational speed from 350mS to 275mS
1. X-ray Generator is changed to match dose at new speed
1. Tube has hardware enhancements to allow for higher rotational speed
1. View rates have been increased

Page 2 of 3

{2}------------------------------------------------

16. SAFETY:

The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.

17. TESTING

Image Quality metrics utilizing phantoms are provided in 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.

18. CONCLUSION

The modifications incorporated into the Aquilion ONE Vision, TSX-301C/1, v4.90 do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

SEP 21 2012

Re: K122109

Trade/Device Name: Aquilion ONE Vision, TSX-301c/1, v4.90 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 16, 2012 Received: July 17, 2012

Dear Mr. Biggins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premains is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Citiestic) to tegans mannent date of the Medical Device Amendments, or to Conimeres prior to May 20, 1978, the eccordance with the provisions of the Federal Food, DINA de vices mat have occh rechasinou in actre approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierefore, market the device, boode requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such IT your device is Classified (see above) interest affecting your device can be found in Title 21, additional contors. Existing mayor regulations of the 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 Please be auvised that FDA s issuation of a succession in ther requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a determination that your as read by other Federal agencies. You must of any Federal statutes and regulations ammitted to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

{4}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related adverses vrelity systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the quality of evice as described in your Section 510(k) premarket witi anow you to begin mainential equivalence of your device to a legally marketed nontication. The I Dry intellig of cassion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific ad rior to: your its a vice Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours, Janine M. Mon

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:

Aquilion ONE Vision, TSX-301C/1, v4.90

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign Off)

Division Sian-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K122109

Regulation Number and Section

§ 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.