Predicate Devices

Reference Devices

K051833, K142465, K072693, K063184, K090504, K090220, K113715, K072737, K142465, K023760, K043111, K142465, K130960, K133324, K132523, K132813, K142465, K142465, K143294, K143294, K142465

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard CT scanner and its image processing capabilities, but there is no mention of AI, ML, or related terms. The performance studies focus on traditional image quality metrics and equivalence to a predicate device, not on AI/ML performance metrics.

Therapeutic

No
The device is indicated for acquiring and displaying cross-sectional volumes for diagnostic purposes, not for active treatment or therapy.

Diagnostic

Yes
The device is a CT scanner designed to acquire and display cross-sectional volumes of the whole body and organs, allowing trained physicians to perform specialized studies and obtain images of "diagnostic quality," indicating its use in diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display." This clearly indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the Aquilion ONE is a Computed Tomography (CT) scanner. CT scanners use X-rays to create cross-sectional images of the inside of the body. This is an in vivo imaging technique, meaning it is performed on a living organism.
Intended Use: The intended use is to "acquire and display cross sectional volumes of the whole body." This involves imaging the patient directly, not analyzing samples taken from the patient.

Therefore, the Aquilion ONE is a medical imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 orqan by a trained and qualified physician.

Product codes

JAK

Device Description

Aquilion ONE (TSX-305A/3) V7.3 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 Toshiba CT systems.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography x-ray

Anatomical Site

whole body, to include the head, Whole organs include but are not limited to brain, heart, pancreas, etc.

Indicated Patient Age Range

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which validated that the substantially equivalent to the predicate device with regard to spatial resolution, CT number magnitude/uniformity, noise properties and low contrast detectability/CNR performance.

Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K142465

Reference Device(s)

K051833, K142465, K072693, K063184, K090504, K090220, K113715, K072737, K142465, K023760, K043111, K142465, K130960, K133324, K132523, K132813, K142465, K142465, K143294, K143294, K142465

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

June 9, 2016

Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K160587

Trade/Device Name: Aquilion ONE (TSX-305A/3) V7.3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 29, 2016 Received: March 2, 2016

Dear Mr. 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K160587

Device Name

Aquilion ONE (TSX-305A/3) V7.3

Indications for Use (Describe)

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 orqan by a trained and qualified physician.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) SUMMARY

1. SUBMITTER'S NAME:

Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

2. OFFICIAL CORRESPONDENT:

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

3. ESTABLISHMENT REGISTRATION:

9614698

4. CONTACT PERSON:

Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

5. Date Prepared:

May 24, 2016

1. TRADE NAME(S): Aquilion ONE (TSX-305A/3) V7.3
1. COMMON NAME: System, X-ray, Computed Tomography
1. DEVICE CLASSIFICATION (Regulatory Class, CFR Reference, Name): Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)

9. PRODUCT CODE / DESCRIPTION:

JAK / Computed Tomography X-Ray System

10. PERFORMANCE STANDARD:

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

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11. PREDICATE DEVICE:

Product	Marketed by	Regulation Number
Aquilion
ONE Vision,
TSX-301C/
6-8, V7.0	Toshiba
America
Medical
Systems	21 CFR
892.1750	Computed
Tomography
X-ray System	JAK:
System, X-ray,
Tomography,
Computed	K142465	03/10/2015

12. REASON FOR SUBMISSION:

New device.

13. DEVICE DESCRIPTION:

Aquilion ONE (TSX-305A/3) V7.3 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 Toshiba CT systems.

14. INDICATIONS FOR USE:

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.

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE (TSX-305A/3) V7.3, is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1-8, V7.0, which received premarket clearance under K142465, marketed by Toshiba America Medical Systems. The Indications for Use for the subject device are identical to those of the predicate device. A comparison of the technological characteristics between the subject and the predicate devices is included below.

| ltem | Aquilion ONE
(TSX-305A/3) V7.3 | Aquilion ONE
(TSX-301C/6-8) V7.0 |
|-----------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k) Number | This submission | K142465 |
| Gantry Rotation Speed | 0.35s
(Optional max 0.275s available
with software upgrade kit) | 0.275s
(Standard on /6 model,
available with software
upgrade kit for /7 and /8
models) |
| View rate | Maximum: 2910 views/s | Maximum: 2910 views/s |
| Detector | 896 channels x 320 rows | 896 channels x 320 rows |
| Pitch factor | 0.555 to 1.575 | 0.555 to 1.5 |
| FOV (field of view) | 240/320/500mm | 180/240/320/400/500mm |

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| Item | Aquilion ONE
(TSX-305A/3) V7.3 | Aquilion ONE
(TSX-301C/6-8) V7.0 | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510(k) Number | This submission | K142465 | |
| Wedge filter types | Two types | Three types | |
| X-ray tube voltage / X-ray tube
current | Max. 72 kW (Max.90kW*)
80/100/120/135 kV

10 to 600 mA (10-900 mA*)
(in steps of 10 mA)

*Option: Available when Fast
Scan Kit and X-ray Power Up Kit,
CGS-56A, is installed | TSX-301C/6:
Max. 90 kW
80/100/120/135 kV

10 to 900 mA
(in steps of 10 mA)

TSX-301C/7 and /8:
Max. 72 kW
80/100/120/135 kV

Previously cleared software options being implemented to the subject device:

Application	510(k) Clearance	Comments
Orbital-synchronization helical scan system
(Sure Subtraction for Neck)	Previously cleared
under K051833	No change
vHP (Variable Helical Pitch)	Previously cleared
under K142465	No change
Neuro Package	Previously cleared
under K072693	No change
Vessel View	Previously cleared
under K063184	No change
Body Perfusion	Previously cleared
under K090504	No change

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Application	510(k) Clearance	Comments
Colon View	Previously cleared
under K090220	No change
Lung Volume Analysis	Previously cleared
under K113715	Workflow improvement(s)
implemented in V7.3
suRECardio Scoring	Previously cleared
under K072737	No change
Dental Package	Previously cleared
under K142465	No change
CT Cardiac Function Analysis Software	Previously cleared
under K023760	No change
surEPlaque	Previously cleared
under K043111	No change
Subtraction Protocol
(SURESubtraction Scan System)	Previously cleared
under K142465	No change
sureSubtraction Ortho
(CSSO-001A)	Previously cleared
under K130960	No change
surESubtraction Lung
(CSSL-001A)	Previously cleared
under K133324	Workflow improvement(s)
implemented in V7.3
MyoPerfusion
(CSMP-001A)	Previously cleared
under K132523	Workflow improvement(s)
implemented in V7.3
Dual Energy System Package
(CSDP-001A)	Previously cleared
under K132813	Workflow improvement(s)
implemented in V7.3
4D Orthopedic Analysis
(CSOA-001A)	Previously cleared
under K142465	No change
4D Cerebral Artery Morphological Analysis
(CSAM-001A)	Previously cleared
under K142465	No change
Adaptive Motion Correction
(CSMC-001A)	Previously cleared
under K143294	No change
4D Airways Analysis
(CSAA-001A)	Previously cleared
under K143294	Workflow improvement(s)
implemented in V7.3
surEExposure 3D	Previously cleared
under K142465	No change

16. 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, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, 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.

17. TESTING

Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which validated that the substantially equivalent to

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the predicate device with regard to spatial resolution, CT number magnitude/uniformity, noise properties and low contrast detectability/CNR performance.

Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.

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 subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

18. CONCLUSION

The Aquilion ONE (TSX-305A/3) V7.3 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 is substantially equivalent in safety and effectiveness to the predicate device.