TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING

K061187 · Toshiba America Medical Systems, In.C · JAK · May 12, 2006 · Radiology

Device Facts

• Record ID: K061187
• Device Name: TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: May 12, 2006
• 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 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. Additionally this device will employ respiratory gating to reduce motion artifacts and improve targeting of anatomy for use with other cleared devices. This device employs no intended uses that are not in cleared devices already found in the marketplace.

Device Story

Device is a CT scanner (Aquilion LB) modified with CKRS-003A Respiratory Gating Option. Inputs: X-ray transmission data. Transformation: Hardware/software modifications enable respiratory gating to synchronize image acquisition with patient breathing cycles. Output: Cross-sectional CT images across all respiratory phases. Used in clinical settings by radiology professionals. Gating reduces motion artifacts; improves anatomical targeting for clinical procedures. Benefits: Enhanced image clarity for diagnosis of tumors, lesions, and trauma; improved accuracy for motion-sensitive anatomy.

Clinical Evidence

No clinical data provided; bench testing only. Device conforms to IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44 safety standards.

Technological Characteristics

CT scanner with respiratory gating hardware/software. Conforms to 21 CFR 1020.30 and 1020.33 (Federal Diagnostic X-ray Equipment Standard). Safety compliance with IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44. Connectivity and specific software architecture details not provided.

Indications for Use

Indicated for X-ray imaging of the whole body using Computerized Tomography, including axial volumetric (helical) CT, CT fluoroscopy, and respiratory (4D) gated scanning for the evaluation of respiration-induced motion by acquiring and displaying CT images across all respiratory phases.

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-201A Aquilion LB (K050458)
• Varian HPM (K983629)

Submission Summary (Full Text)

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# MAY 12 2005

# 510(k) Summary

| Date: | April 10, 2005 |
|---------------------------------------|----------------------------------------------------------------------------|
| 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:<br>[phone] | Paul Biggins, Regulatory Affairs Specialist, |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | TSX-201A Aquilion LB with Respiratory<br>Gating |
| Common Name:<br>90JAK] | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code: |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard:<br>Standard | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment |
| Predicate Device(s): | TSX-201A Aquilion LB k050458<br>Varian HPM k983629 |
| Reason For Submission | Modification of cleared device |

## Description of this Device:

The CKRS-003A Respiratory Gating Option will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires hardware and software modifications to the existing 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

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K06 US87
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examine musculoskeletal degeneration. Additionally this device will employ respiratory gating to reduce motion artifacts and improve targeting of anatomy for use with other cleared devices. This device employs no intended uses that are not in cleared devices already found in the marketplace.

#### Technological Characteristics:

This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results.

#### 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, 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 60601-1 {applicable portions}; IEC 60601-2-32 and IEC 60601-2-44. - Medical Device Safety standards.

### Substantial Equivalence:

Toshiba TSX-201A, Aquilion LB CT cleared via k050458 Varian RPM Respiratory Gating System cleared via k983629

Toshiba America Medical Systems, Inc. believes that the combination of the two devices does not change the intended use of either device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 1 2 2006

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

Re: K061187

Trade/Device Name: Toshiba TSX-201A, Aquilion LB CT System with Respiratory Gating (CKRS-003A)

Regulation Number: 21 CFR 892.1750

Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 25, 2006 Received: April 28, 2006

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.

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Preventing and Promoting Public Health

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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.

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 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" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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 _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

### K661187

Device Name: Toshiba TSX-201A, Aquilion LB CT System with Respiratory Gating (CKRS-003A

Indications for Use:

X-ray imaging of whole body - Computerized Tomography Including;

> Axial Volumetric (Helical) CT Fluoroscopy Respiratory (4D) Gated Scanning

Respiratory Gated (4D) Scanning on the Aquilion LB is a non-invasive software/hardware option that can be used for the evaluation of respiration-induced motion by acquiring and displaying CT images consisting of all respiratory phases during a breathing cycle

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR§801.109)

Over-The-Counter Use

(Optional Format 1-2-96) Division Sign-Off) Division of Reproductive, Abdominal.

OR

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