TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS

K033418 · Toshiba America Medical Systems, In.C · JAK · Nov 10, 2003 · Radiology

Device Facts

• Record ID: K033418
• Device Name: TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Nov 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The TSX-101A CT Scanners are indicated for head and whole body computed tomography applications. X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

Device Story

TSX-101A/A and TSX-101A/C are multislice CT scanners consisting of gantry, patient table, image acquisition hardware/software, and operator console. Device acquires X-ray data to produce cross-sectional images of head and whole body. Used in clinical settings by trained medical professionals. Output images assist clinicians in diagnostic decision-making. Benefits include high-resolution anatomical visualization for patient diagnosis.

Clinical Evidence

Bench testing only. Device evaluated for electrical, mechanical, and radiation safety; conforms to applicable medical device safety and performance standards.

Technological Characteristics

Multislice CT scanner system. Materials and construction compliant with IEC60601-1 and 21 CFR Subchapter J. Includes gantry, patient table, and operator console. Software-based image acquisition and processing.

Indications for Use

Indicated for head and whole body computed tomography applications, including axial volumetric (helical) scanning and CT fluoroscopy, for patients requiring diagnostic X-ray imaging.

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/8 Aquilion 16 CT
• TSX-101A/7 Aquilion Super 4 CT (K031469)

Reference Devices

• Aquilion CT Scanner Multi-slice 16 (CGS-31A) (K022050)

Submission Summary (Full Text)

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## NOV 1 0 2003

# 510(k) Summary

This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements set forth in 21 CFR 807.87(h).

| Date: | October 17, 2003 |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| Submitter: | Toshiba America Medical Systems, Inc.<br>P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins<br>Senior Manager, Regulatory Affairs<br>Telephone: [phone]; Fax: [phone] |
| Device Proprietary Name: | TSX-101A/A and TSX-101A/C Aquilion Multislice CT Scanners |
| Common Name: | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code: 90JAK] |
| Predicate Device(s): | TSX-101A/8 Aquilion 16 CT<br>TSX-101A/7 Aquilion Super 4 CT |

#### Description of this Device:

The Aquilion TSX101A/A and TSX-101A/C CT Scanner Systems are composed of a gantry, patient table, image acquisition hardware and software, an operator console and associated accessories. Materials and construction are similar to the Aquilion CT Scanner Multi-slice 16 (CGS-31A) [K022050] and the TSX-101A/7 Aquilion Super 4 CT Scanner [K031469], and are compliant with IEC60601-1 and associated collateral and particular standards, and applicable sections of 21 CFR Subchapter J.

### Indications for Use:

The TSX-101A CT Scanners are indicated for head and whole body computed tomography applications.

### Comparison with Predicate Devices

The TSX-101A/A and TSX-101A/C Computed Tomography Systems are modifications of and are of comparable type and substantially equivalent to the currently marketed Toshiba TSX-101A/7 and TSXC-101A/8 CT Systems. They employ the same technological characteristics, are comparable in regards to primary concerns of safety and effectiveness, employ the same basic design, construction, materials and have the same intended use as the predicate devices.

### Summary of Studies:

These devices have been evaluated for electrical, mechanical, and radiation safety. Furthermore they conform to applicable medical device safety and performance standards.

### Conclusion

Intended use and technologies are the predicate Toshiba devices listed above. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 9001/13485 quality systems. Additionally these devices conform to applicable medical device safety and performance standards. It is the opinion of Toshiba America Medical Systems that these devices are substantially equivalent to the legally marketed predicate devices.

,

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Image /page/1/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, with three lines representing the figure's body and arms. The figure is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 2003

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

Re: K033418 Trade/Device Name: TSX-101A/A and TSX-101A/C Aquilion CT Scanners Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 23, 2003 Received: October 27, 2003

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 (PMA), 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 (OS) 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) 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 the 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

#### TSX-101A/A and TSX-101A/C Aquilion CT Scanners Device Name:

Indications for Use:

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

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CT Fluoroscopy

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| | | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| | | <img src="signature"/> |
| | (Division Sign-Off)<br>Division of Reproductive, Abdominal,<br>and Radiological Devices<br>510(k) Number | K033418 |
| Prescription Use<br>(Per 21 CFR 801.109)<br><div> <img src="check"/> </div> | OR | Over-The-Counter Use ______ |
| | (Optional Format 1-2-96) | |