AQUILION PRIME

K120710 · Toshibamedical Systems Corporation · JAK · Apr 6, 2012 · Radiology

Device Facts

• Record ID: K120710
• Device Name: AQUILION PRIME
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Apr 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Prime has the capability to provide volume sets. These volume sets can then be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Device Story

The TSX-302A/2 Aquilion Prime is a 40-row CT system designed for whole-body imaging, including the head. It acquires X-ray projection data, which is processed to generate cross-sectional volume sets. These volumes are displayed for clinical review and specialized diagnostic studies. The device is intended for use in clinical environments by trained and qualified physicians. It functions as a diagnostic imaging tool, providing clinicians with anatomical information to support clinical decision-making and patient diagnosis. The system is a modification of the previously cleared Toshiba TSX-302A, utilizing established CT technology and materials.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

40-row CT system. Materials and technology based on previously marketed Toshiba CT systems. Designed in conformance with IEC safety standards and 21 CFR 1020 radiation safety requirements. Manufactured under ISO-13485 and 21 CFR 820 quality systems.

Indications for Use

Indicated for acquisition and display of cross-sectional whole-body volumes, including the head, for use by trained physicians in specialized studies.

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 Aquilion PRIME TSX-302A (k110066)

Submission Summary (Full Text)

{0}------------------------------------------------

K120410

Toshiba America Medical Systems, Inc. Pre-market Notification 510(k) TSX-302A/2, Aquilion Prime CT System

APR - 6 2012

# 510(k) Summary

Date:

March 6, 2012

Manufacturer:

Toshiba Medical Systems Corporation 1385 Shimoishigami, Otawara-shi, Tochigi-ken, 324-8550, Japan

Toshiba America Medical Systems, Inc.

Paul Biggins, Director Regulatory Affairs

Scanner, Computed Tomography, X-Ray

P.O. Box 2068, 2441 Michelle Drive,

Tustin, CA 92781-2068

TSX-302A/2, Aquilion Prime

II (per 21 CFR 892.1750)

[phone]

2020563

90-JAK

None

Initial Importer/Distributor: Address:

Contact:

Establishment Registration Number:

Device Proprietary Name:

Common Name:

Classification :

Regulatory Class:

Performance Standard:

Predicate Device(s):

Reason for Submission

Modification to cleared device

Toshiba TSX-302A, k110066

Description of this Device:

The TSX-302A/2 is a 40-row CT System that is intended to produce axial scans of the whole body to include the head. The TSX-302A/2 is based upon the technology and materials of previously marketed Toshiba CT systems.

{1}------------------------------------------------

### Toshiba America Medical Systems, Inc. Pre-market Notification 510(k) TSX-302A/2, Aquilion Prime CT System

#### Summary of Intended Uses:

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. ·

The Aquilion Prime has the capability to provide volume sets. These volume sets can then be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

#### Substantial Equivalence:

This device is substantially equivalent to the predicate devices which are commercially available at this time.

Toshiba Aquilion PRIME TSX-302A; k10066

#### Safety:

This device is designed and manufactured under ISO-13485 to include meeting the requirements of 21 CFR 820. Additionally this system is designed and manufactured in conformance with the appropriate IEC safety standards. This includes the employment of risk mitigation during the development of this device.

Radiation safety is assured by meeting the associated requirements of 21 CFR 1020. This information is provided to the FDA in compliance with the required CT product reports.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the graphic.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation, JAPAN % Mr. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Dr. TUSTIN CA 92780

Re: K120710

Trade/Device Name: TSX-302A/2, Aquilion Prime CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, IYO, and ITX Dated: March 6, 2012 Received: March 8, 2012

Dear Mr. Biggins:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

APR - 6 2012

{3}------------------------------------------------

#### Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use Form

510(k) Number (if known): __

Device Name: TSX-302A/2, Aquilion Prime CT System

Indications for Use:

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:middle;">✓</div> |
|-------------------------------------------------------|-------------------------------------------------------------------|
| AND/OR Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Andrew O'Keefe

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120716

Page 1 of