ASTEION CT SCANNER, TSX-021A

K982787 · Toshiba America Medical Systems, In.C · JAK · Oct 21, 1998 · Radiology

Device Facts

• Record ID: K982787
• Device Name: ASTEION CT SCANNER, TSX-021A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image 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.

Device Story

Asteion (TSX-021A) is a whole-body CT scanner using slip-ring technology for continuous 360-degree rotation of x-ray tube and detector. Device acquires transmission data axially or volumetrically (helical) via table movement. Microprocessor-based computer reconstructs data into 2D cross-sectional images; supports 3D rendering and CT fluoroscopy. Operated by clinical staff in a radiology setting. Output consists of black and white images for display, film, or electronic storage. Clinicians use images to diagnose injuries, tumors, lesions, and obstructions, and to evaluate musculoskeletal degeneration. Benefits include non-invasive visualization of internal anatomy for clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Whole-body CT scanner; slip-ring technology; high-frequency x-ray controller; solid-state x-ray detector; microprocessor-based computer for data reconstruction. Supports axial and helical acquisition. Connectivity via DICOM (NEMA-PS3). Conforms to IEC-60601 safety standards. Manufactured under 21 CFR 820 Quality System Regulations.

Indications for Use

Indicated for whole body X-ray imaging via Computerized Tomography, including axial, volumetric (helical), and CT fluoroscopy. Used for diagnosis of spine/head injuries, intracranial tumors, brain blood clots, eye trauma, extremity soft tissue lesions, GI lesions, abdominal/pelvic malignancies, hepatic metastases, intestinal obstructions, intra-abdominal abnormalities, and musculoskeletal degeneration.

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

• Toshiba TSX-011A, Xpress (K903701/A)

Submission Summary (Full Text)

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OCT 21 1998

# 510(k) Summary

K982787

| Date: | 5 August 1998 |
|---------------------------------------|---------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist, [phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | Asteion CT Scanner, TSX-021A |
| Common Name: | Scanner, Computed Tomography, X-Ray JAK<br>[Fed. Reg. No. 892.1750, Pro. Code: 90JXD] |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Predicate Device: | Toshiba TSX-011A, Xpress [K903701/A] |
| Reason For Submission | New Product |

### Description of this Device:

The Asteion (TSX-021A) is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data, as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "slice" of the body. As is common with today's CT Scanner, the Asteion has the capability to acquire volumetric (helical) data by initiating table movement during data This data can be reconstructed per the operator's preference, to include three acquisition. dimensional rendering of the patient data. Additionally the TSX-021A is capable of CT Fluoroscopy, which is used on other Toshiba CT scanners and has received previous market clearance from the Agency. This device incorporates a standard x-ray tube and a solid state x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.

### Summary of Intended Uses:

This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image 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.

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This device employs no intended uses that are not in cleared devices already found in the marketplace.

#### Technological Characteristics:

This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component 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. Both of these devices produce two dimensional, black and white image that can be filmed or electronically stored for future review.

## Conformance to Standards:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Additionally this system is in conformance with the applicable parts of the following Standards:

> IEC-60601 - Medical Device Safety NEMA-PS3 - DICOM Standard

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that suggest movement and flight. The overall design is simple and clean, with a focus on the eagle as a symbol of strength and freedom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068

Re: K982787

> Asteion CT Scanner. TSX-021A Dated: August 5, 1998 Received: August 10, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Biggins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Federal Food, Drug, and Cosmetic Act (Act. Xou 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 sanst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (11-CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition: FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 OFR Part 801 and additionally 809:10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrf/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ____Asteion CT Scanner_TSX-021A

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Gamil A. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Prescription Use _ 1 (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)