CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A

K020385 · Toshiba America Medical Systems, In.C · JAK · Feb 15, 2002 · Radiology

Device Facts

• Record ID: K020385
• Device Name: CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Feb 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for 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 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.

Device Story

The CGS-30A Multislice Upgrade Kit modifies the Aquilion CT Scanner (TSX-101A) to enable collection of eight axial slices per rotation. The system uses multiple solid-state detectors to acquire high-resolution x-ray transmission data; a computer reconstructs this data into two-dimensional, black-and-white cross-sectional images. Operated by clinicians in a hospital or clinical setting, the device reduces anatomical motion artifacts through increased scan speed. Output images are stored electronically or filmed for diagnostic review by physicians to evaluate injuries, tumors, lesions, and musculoskeletal conditions. The upgrade enhances diagnostic capabilities by providing higher-resolution volumetric data compared to previous configurations.

Clinical Evidence

Bench testing only. The device relies on the established safety and effectiveness of the predicate Aquilion CT system. Conformance to 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard) and IEC-60601 safety standards is documented.

Technological Characteristics

System consists of high-frequency x-ray controllers, solid-state x-ray detectors, and a computer reconstruction unit. Produces 2D black-and-white images. Complies with 21 CFR 1020.30, 1020.33, and IEC-60601. Upgrade increases slice acquisition capacity to eight slices per rotation.

Indications for Use

Indicated for X-ray imaging of the whole body using Computerized Tomography, including Axial Volumetric (Helical) CT and CT Fluoroscopy. Intended for prescription use.

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

• CGS-22A Multislice Upgrade kit for the Aquilion CT TSX-101 A

Reference Devices

• GE Lightspeed Ultra (K013651)

Submission Summary (Full Text)

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FEB 1 5 2002

KO20385

## 510(k) Summary

| Date: | January 18, 2002 |
|---------------------------------------|---------------------------------------------------------------------------------------------|
| 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 Manager, [phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner,<br>TSX-101A(Aquilion Advance Multi) |
| Common Name: | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code: 90JAK] |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard: | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | CGS-22A Multislice Upgrade kit for the Aquilion CT<br>TSX-101 A |
| Other Similar Devices: | GE Lightspeed Ultra (K013651) |
| Reason For Submission | Modification of cleared device |

#### Description of this Device:

The Multislice kit is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265]. This upgrade will allow for the collection of eight axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high resolution slices while maintaining the speed required to reduce anatomical motion artifacts.

#### 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 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.

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K020385
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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. This device produces two dimensional, black and white images that can be filmed or electronically stored for future review.

### Safety and Effectiveness Concerns:

Bareer and manufactured under the Quality System Regulations as outlined in 21 CFR 8 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that 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 this upgrade package, Multislice CT, CGS-30A, is substantially equivalent to the CGS-22A upgrade kit for Aquilion CT scanner. The major difference is the number of slices being collected in a single rotation.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three wavy lines that resemble a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

Toshiba America Medical Systems, Inc. Re: K020385 % Mr. Mark Job TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Trade/Device Name: CGS-30A Multislice Upgrade kit for Aquilion CT Scanner Model TSX-101A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 4, 2002 Received: February 5, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device 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 encreated of the enactment date of the Medical Device Amendments, or to conniner of the to ria) 2011-12-11 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 I ou may , aterest, 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 r touse of action and I termination 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 (21 CFR Part 807), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorth in also quind provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nothication. The FDA intellig of succeantal organ 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 If you desire specific advice for your de of the following numbers, based on the regulation number at the top of this 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 Additionally, for questions on the premiers of the regulation entitled, "Misbranding Other of Compilance at (201) 37 - 1007.97). Other general information on by reletence to premained the Act may be obtained from the Division of Small Manufacturers, your responsibilities and Consumer Assistance at its toll-free number [phone] or [phone] methatronal and Ocress 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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KC020385

1 of Page l

510(k) Number (if known):

Multislice Upgrade kit (CGS-30A) for the Aquilion CT Scanner TSX-101A Device Name:

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)

Nancy Brogdon

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

SKAI

/ 300/10000

(Optional Format 1-2-96)