TSX-201A AQUILION LB CT SCANNER

K050458 · Toshiba America Medical Systems, In.C · JAK · Mar 10, 2005 · Radiology

Device Facts

• Record ID: K050458
• Device Name: TSX-201A AQUILION LB CT SCANNER
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Mar 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 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.

Device Story

Aquilion LB is a multi-slice helical CT system comprising a gantry, patient couch, and console. It utilizes high-frequency X-ray controllers to generate radiation, which is captured by a multi-row detector. The system reconstructs X-ray transmission data into 2D and 3D black-and-white images. Operated by clinical staff in a radiology setting, the device provides images for diagnostic review by physicians to assess injuries, tumors, lesions, and other abnormalities. The output is stored electronically or filmed, facilitating clinical decision-making regarding patient diagnosis and treatment planning.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing/compliance with established performance standards (21 CFR Subchapter J and IEC-60601).

Technological Characteristics

Multi-slice helical CT system; high-frequency X-ray controllers; selectable slice-thickness multi-row detector; computer-based image reconstruction; produces 2D/3D black and white images. Complies with 21 CFR 1020.30, 1020.33, and IEC-60601.

Indications for Use

Indicated for whole body X-ray imaging using Computerized Tomography, including axial, volumetric (helical), and CT fluoroscopy. Intended for diagnostic imaging of patients requiring evaluation of spine/head injuries, tumors, blood clots, trauma, lesions, malignancies, obstructions, 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

• TSX-101A, Aquilion MS-16 (K022050)

Submission Summary (Full Text)

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# 510(k) Summary

MAR 1 0 2005

| Date: | January |
|---------------------------------------|-----------------------------------------------------------------------------------|
| 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, Senior Manager Regulatory Affairs<br>[phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | TSX-201A, Aquilion LB CT Scanner |
| 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): | TSX-101A, Aquilion MS-16 [k022050] |
| Reason For Submission | Modification of cleared device |

## Description of this Device:

The Aquilion LB is a multi-slice helical CT system, consisting of a gantry, patient couch and console. The system generates up to 32 axial slices per second using a selectable slice-thickness multi-row detector.

## 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. 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

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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 and three-dimensional, black and white 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, 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 Aquilion LB CT scanner is substantially equivalent to the predicate Aquilion MS-16 CT scanner [k022050].

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Image /page/2/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird is composed of three curved lines that suggest wings and a body. The logo is encircled by text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES' in a circular arrangement around the bird. The text is in all capital letters and is smaller than the central bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2005

Toshiba America Medical Systems, Inc. c/o Mr. Mark Job Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K050458

Trade/Device Name: Aquilion LB CT Scanner TSX-201A Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 18, 2005 Received: February 23, 2005

Dear Mr. Job:

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 (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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manxeting of substantial equivalence of your device to a legally premarket nothleation. "The I Dri munity of bactuation 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 If you desire specific advice for your cerros on our of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation emilited, formation on your responsibilities under the Act from the 807.97). You may obtain other general information on your Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hodgdon

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 l of l

KUS 0458 510(k) Number (if known):

Aquilion LB CT Scanner TSX-201A Device Name:

Indications for Use:

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

David G. Leppmann

(Division Sign-Off) (Division Sign-Coluctive, Abdominal, 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)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)