AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7

• K Number: K031469
• Device Name: AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
• Manufacturer: TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
• Date Cleared: 2003-05-22 ( 13 days)
• Product Code: JAK
• Regulation Number: 892.1750

Intended Use

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

Device Description

The Aquilion Super 4 CT Scanner is similar to the Aquilion Multislice CT scanner. The major difference between the two devices is a change of hardware in the computational subsystem and an improved patient couch. This device uses the same software and scanning hardware as the predicate device.

Predicate Devices

TSX-101A Aquilion CT w/ CGS-22A

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states that the device uses the same software as the predicate device and mentions no new features related to AI or ML.

Therapeutic

No
The device is described as an X-ray imaging system (CT scanner) used for diagnostic purposes (imaging of the whole body), not for treating a disease or condition.

Diagnostic

Yes
Justification: The device's intended use is "X-ray imaging of whole body - Computerized Tomography," which is a diagnostic imaging technique used to visualize internal structures for medical diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states changes in hardware (computational subsystem and patient couch) and refers to "scanning hardware," indicating it is a hardware-based medical device with associated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is "X-ray imaging of whole body - Computerized Tomography". This describes an imaging device used to visualize internal structures of the body.
• Device Description: The description details a CT scanner, which is an imaging modality.
• Input Imaging Modality: The input is "x-ray transmission data", which is used to create images, not to analyze biological samples.
• Anatomical Site: The anatomical site is "whole body", indicating it's used on a living patient.

IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device operates on the body to create images.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

Product codes

90JAK

Device Description

The Aquilion Super 4 CT Scanner is similar to the Aquilion Multislice CT scanner. The major difference between the two devices is a change of hardware in the computational subsystem and an improved patient couch. This device uses the same software and scanning hardware as the predicate device.

This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. This device produces digital images that can be filmed or electronically stored for future review.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-ray, CT

Anatomical Site

human body, spine, head, intracranial, brain, eye, soft tissue (extremities), gastrointestinal, abdominal, pelvic, hepatic, musculoskeletal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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

Not Found

Predicate Device(s)

TSX-101A Aquilion CT w/ CGS-22A

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

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

0

510(k) Summary

| Date: | April 8, 2003
MAY 22 2003 |
|----------------------------------------|--------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,
Tustin, CA 92781-2068 |
| Submitter's Contact:
[phone] | Paul Biggins, Regulatory Affairs Manager, |
| Establishment Registration
Number: | 2020563 |
| Device Proprietary Name: | TSX-101A/7, Aquilion Super 4 Multislice
CT Scanner |
| Common Name: | Scanner, Computed Tomography, X-Ray
[Fed. Reg. No. 892.1750, Pro. Code:
90JAK] |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard:
Standard | 21 CFR Subchapter J,
Federal Diagnostic X-ray Equipment |
| Predicate Device(s):
Multislice kit | TSX-101A Aquilion CT w/ CGS-22A |
| Reason For Submission | Modification of cleared device |

Description of this Device:

The Aquilion Super 4 CT Scanner is similar to the Aquilion Multislice CT scanner. The major difference between the two devices is a change of hardware in the computational subsystem and an improved patient couch. This device uses the same software and scanning hardware as the predicate device.

Summary of Intended Uses:

This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

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Technological Characteristics:

This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. This device produces digital images that can be filmed or electronically stored for future review.

Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, which apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.

Substantial Equivalence:

Based upon the above considerations TAMS believes that the Aquilion Super 4 CT System is substantially equivalent to the TSX-101A, Aquilion CT scanner. The major difference is a change in the configuration of the computational subsystem.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ----

MAY 22 2003

Toshiba America Medical Systems, Inc. c/o Ms. Laura Danielson Responsible Third Party Official TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K031469

Trade/Device Name: Aquilion Super 4 CT Systems, TSX-101A/7 Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: May 8, 2003 Received: May 9, 2003

Dear Ms. Danielson:

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.

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); 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.

3

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Aquilion Super 4 CT System; TSX-101 A/7 Device Name: Indications for Use:

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

Daniel A. Lyons

(Division Sign-Off Division of Reproductive, Ab and Radiological Devices 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________