TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER

K051833 · Toshiba America Medical Systems, In.C · JAK · Jul 15, 2005 · Radiology

Device Facts

• Record ID: K051833
• Device Name: TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Jul 15, 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 ray transmoses in cally 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 pelyic 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

Multi-slice helical CT system comprising gantry, patient couch, and console. Inputs: X-ray transmission data acquired at different angles. Transformation: High-frequency X-ray controller generates radiation; multi-row detector captures data; computer reconstructs cross-sectional images. Outputs: 2D and 3D black and white images for clinical review/storage. Used in clinical settings by trained medical professionals. Output facilitates diagnosis of injuries, tumors, lesions, and malignancies; aids in evaluating obstructions and musculoskeletal conditions. Benefits patient through non-invasive diagnostic imaging.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and compliance with established performance standards (21 CFR Subchapter J, IEC-60601).

Technological Characteristics

Multi-slice helical CT system; high-frequency X-ray controller; multi-row detector; 2D/3D image reconstruction; 128 axial slices per second; compliant 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) CT and CT fluoroscopy, for diagnostic evaluation of spine/head injuries, tumors, blood clots, trauma, lesions, malignancies, metastases, 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/A, /C, Aquilion MS-64/Aquilion MS-32 (K033418)

Submission Summary (Full Text)

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JUL 1 5 2005

K051833
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# 510(k) Summary

| Date: | June 20, 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: | Paul Biggins, Senior Manager Regulatory Affairs,<br>[phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | TSX-101A/H Aquilion 64 SP<br>TSX-101A/I Aquilion 32 SP |
| 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/A, /C,Aquilion MS-64/Aquilion MS-32 [k033418] |
| Reason For Submission | New device |

### Description of this Device:

The Aquilion 32/64 SP is a multi-slice helical CT system, consisting of a gantry, patient couch and console. The system generates up to 128 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 ray transmoses in cally 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 pelyic 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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K051833
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#### 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 then ricquency is ray comisers cay 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:

Dater and interior on one of consistered 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 SP-32/64 scanners are substantially equivalent to the predicate Aquilion MS-32/64 CT scanners [k033418].

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be a stylized depiction of an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051833

JUL 1 5 2005

Trade/Device Name: TSX-101A/H Aquilion 64 SP CT Scanner and TSX-101A/I Aquilion 32 SP CT Scanner Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II

Product Code: JAK Dated: June 30, 2005 Received: July 6, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your bother device is substantially equivalent (for the indications for use stated in above and have determinerarketed predicate devices marketed in interstate commerce prior to the chevosale) to regarly mant date of the Medical Device Amendments, or to devices that have been ready 20, 1776, the charminitions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordal of a premarket approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act device, subject to the generalian, 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 If your device is elassilion (sto such additional controls. Existing major regulations affecting your Apployally, It 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 I Dri mas made a acterininations administered by other Federal agencies. You must comply with all the 1 ot's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling Ave 3 requirements, mercuring practice requirements as set forth in the quality systems (QS) (2) Crice Cr (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)
The start of the Callery of all and started assisse of your device of your devic This letter will allow you to begin makeing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, pe premarket notification. The FDA Inding of substantial or 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), pleased If you desire specific advice for your device on our labering regarities.
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 Also, please note the regulation entitled, "firstonauling of the sunder the Act from the 807.97). You may obtain other general mionnational on Jour responsible at its toll-free number (800) DIVISION OF Binan Mail-6597 or at its Internet address 058-2041 or (2017) or (201) visupport/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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510(k) Number (if known): _

K051833

TSX-101A/H Aquilion 64 SP; TSX-101A/I Aquilion 32 SP 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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051832

Prescription Use ***_***_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use ***_***_

(Optional Format 1-2-96)