AUKLET CT SCANNER, TSX-003A

K973908 · Toshiba America Medical Systems, In.C · JAK · Dec 22, 1997 · Radiology

Device Facts

• Record ID: K973908
• Device Name: AUKLET CT SCANNER, TSX-003A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Dec 22, 1997
• 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, blodd 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

Auklet CT Scanner (TSX-003A) is a whole-body X-ray CT system using slip-ring technology for continuous 360-degree rotation of X-ray tube and xenon gas-filled detector. Device acquires axial and volumetric (helical) transmission data; microprocessor-based computer reconstructs data into 2D cross-sectional images. System supports 3D rendering. Operated by clinical staff in a radiology setting. Output consists of 2D black-and-white images for film or electronic storage. Clinicians use images to diagnose injuries, tumors, lesions, and malignancies, and to evaluate obstructions or degeneration. Benefits include non-invasive visualization of internal anatomy to guide clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and comparison to the predicate device.

Technological Characteristics

Whole-body CT scanner; slip-ring technology; high-frequency X-ray controller; xenon gas-filled X-ray detector; microprocessor-based computer for data reconstruction; hard disk storage; 2D image output; supports axial and volumetric (helical) acquisition.

Indications for Use

Indicated for whole body X-ray computed tomography imaging, including axial and volumetric (helical) scanning, for diagnostic evaluation of spine/head injuries, intracranial tumors, brain blood clots, eye trauma, extremity soft tissue lesions, gastrointestinal 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-002A, Xvision (K941745)

Submission Summary (Full Text)

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K97 3908

## DEG 22 1997

# 510(k) Summary

ﻤﺴﺴﺴ

| Date: | 20 August 1997 | |
|---------------------------------------|-----------------------------------------------------------------------------------|--|
| 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: | Auklet CT Scanner, TSX-003A | |
| Common Name: | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code: 90JXD] | |
| Regulatory Class: | II (per 21 CFR 892.1750) | |
| Predicate Device: | Toshiba TSX-002A, Xvision [K941745] | |
| Reason For Submission | New Product | |

#### Description of this Device:

The Auklet 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 "clice" of the body. As is common with today's CT Scanner, the Auklet has the capability to acquire volumetric (helical) data by initiating table movement during data acquisition. This data can be reconstructed per the operator's preference, to include three dimensional rendering of the patient data. This device incorporates a standard x-ray tube and xenon gas filled 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, blodd 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:

11

This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these system 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.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

Re:

DEC 2 2 1997 K973908 TSX-003A Auklet CT Scanner Dated: October 13, 1997 Received: October 14, 1997 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 ise stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 marked 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 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/cdrh/dsmamain.html".

Sincerely vours

Wiliau Yu
Lillian Yiu, Ph.D.

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

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Page 1 of 1510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

二

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

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

Concurrence of CDRH, Office of Device, Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973908 |

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> | OR | Over-The-Counter Use |
|---------------------------------------|--------------|----|----------------------|
|---------------------------------------|--------------|----|----------------------|

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