AQUILION CXL

K112989 · Toshiba America Medical Systems, In.C · JAK · Apr 10, 2012 · Radiology

Device Facts

• Record ID: K112989
• Device Name: AQUILION CXL
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Apr 10, 2012
• 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 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, gastro intestinal lesions, abdominal and pelvic malignancies and hepatic metastases. CT is also used to evaluate intestinal obstructions, as intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place.

Device Story

Aquilion CXL is a whole-body multi-slice helical CT system comprising gantry, patient couch, and console. System acquires x-ray transmission data at multiple angles; reconstructs data into cross-sectional images. Features include 128-slice capability, active collimation for penumbra reduction, and AIDR dose-reduction algorithm. Operated by trained clinicians in clinical settings. Output images assist physicians in diagnosing head/spine injuries, tumors, blood clots, trauma, lesions, and musculoskeletal degeneration. Updated computer system enables faster reconstruction and increased data storage. Includes ColonView software for colon analysis and SureXtension for extended table weight capacity (up to 300kg).

Clinical Evidence

Bench testing only. Testing utilized phantoms and accepted image quality metrics to verify performance of the 128-slice reconstruction, AIDR algorithm, and active collimation features. No clinical data presented.

Technological Characteristics

Multi-slice helical CT system. Components: gantry, patient couch, console. Detector: multi-row, selectable slice-thickness. Energy: X-ray. Connectivity: Networked console. Standards: 21 CFR Subchapter J, IEC 60601-1, ISO 13485. Features: AIDR algorithm, active collimation, 300kg table capacity.

Indications for Use

Indicated for acquisition and display of axial x-ray images of the whole body, including the head, for diagnostic purposes.

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/H,/I Aquilion 32/64 SP CT System (K080211)

Reference Devices

• SureXtension (K093891)
• ColonView software (K090220)

Submission Summary (Full Text)

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## APR 1 0 2012

Toshiba America Medical Systems, I Pre-Market Notification 510(k) Aquilion CXL, TSX-101A/Q

## 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

- 1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
- 2. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
- 3. ESTABLISHMENT REGISTRATION: 2020563
- 4. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs [phone]
- 5. SUBMISSION DATE October 5, 2011
- 6. TRADE NAME(S): Aquilion CXL, TSX-101A/Q
- 7. COMMON NAME: Scanner, Computed Tomography, X-ray
- 8. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
- 9. PRODUCT CODE / DESCRIPTION: JAK - Computed tomography X-ray system
- 10. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
- 11. PREDICATE DEVICE: TSX-101A/H,/I Aquilion 32/64 SP CT System (K080211)
- 12. REASON FOR SUBMISSION: Modification of a cleared device

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Aquilion CXL.TSX-101A/Q

### 13. DEVICE DESCRIPTION:

The Aquilion CXL is a whole body multi-slice helical CT System, consisting of a gantry, patient couch and console. The system generates up to 128 slices per rotation using a selectable slice-thickness multi-row detector. Additionally, the Aquilion CXL will utilize the new dose-reduction technologies adopted from Aquilion ONE (currently under FDA review), the system substantially reduces patient exposure dose and improves image quality.

#### 14. 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, gastro intestinal lesions, abdominal and pelvic malignancies and hepatic metastases. CT is also used to evaluate intestinal obstructions, as intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place.

#### 15. SUBSTANTIAL EQUIVALENCE:

Toshiba Medical Systems Corporation believes that the Aquilion CXL, TSX-101A/Q CT Scanner is substantially equivalent to TSX-101A/H,/I Aquilion 32/64 SP CT System (K080211).

| New feature | |
|-----------------------------------------------------------------------------|-----------------------------------|
| Maximum number of slices | Changed from 64 to 128 |
| Application of AIDR algorithm | Not available on previous version |
| Computer system is updated | Faster reconstruction |
| | Additional data storage |
| Addition of SureXtension | Previously cleared via K093891 |
| Availability of ColonView<br>software | Cleared via k090220 |
| Table weight is extended to<br>300kg (660lbs.) | Previous weight was 450lbs. |
| Active collimation to reduce<br>penumbra effect during helical<br>scanning. | Not available on predicate |

#### 16. SAFETY:

The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Aquilion CXL,TSX-101A/Q

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applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via an initial report.

#### 17. SUMMARY OF TESTING:

Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device.

#### 18. CONCLUSION

The Aquilion CXL, TSX-101A/Q CT Scanner complies with the same or equivalent standards and has the same intended use as the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

# 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

APR 1 0 2012

Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K112989

Trade/Device Name: Aquilion CXL, TSX-101A/Q Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 12, 2012 Received: March 14, 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

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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 requirements 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

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Toshiba America Medical Systems, Inc.

.

| 510(k) Number (if known): | |
|---------------------------|--------------------------|
| Device Name: | Aquilion CXL, TSX-101A/Q |

Indications for Use:

Acquisition and display of axial x-ray images of the whole body to include the head.

| Prescription Use | <b>X</b> | AND/OR | Over-The-Counter Use |
|-----------------------------|----------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) |

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

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

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) Number | |
|---------------|--|
|---------------|--|

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Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K112989

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Indication for Use

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510k: Aquilion CXL, TSX-101A/Q Page 13 of 2110 . ' ·