Aquilion Lightning (TSX-035A/2, V7.0)

K151833 · Toshibamedical Systems Corporation · JAK · Oct 9, 2015 · Radiology

Device Facts

• Record ID: K151833
• Device Name: Aquilion Lightning (TSX-035A/2, V7.0)
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Indications for Use

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

Device Story

16-row CT system; acquires cross-sectional X-ray volumes of whole body/head. Transforms X-ray attenuation data into diagnostic images via reconstruction algorithms; includes noise reduction (QDS, AIDR 3D, AIDR 3D Enhanced) and metal artifact reduction (SEMAR). Operated by trained personnel in clinical settings. Output viewed by radiologists for diagnostic assessment; supports clinical decision-making through high-resolution imaging. Benefits include diagnostic visualization of internal anatomy.

Clinical Evidence

Bench testing only. Performance validated using phantoms for spatial resolution, CT number, contrast-to-noise ratio, and noise properties. Representative diagnostic images (head, chest, abdomen, pelvis, peripheral) reviewed by an American Board Certified Radiologist confirmed diagnostic quality.

Technological Characteristics

16-row CT system; 800-channel detector; 36 kW max output; 780 mm gantry opening. Software includes QDS, AIDR 3D, AIDR 3D Enhanced, and SEMAR. Conforms to IEC 60601-1, 60601-1-2, 60601-2-44, IEC 62304, IEC 62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26. Complies with 21 CFR 1020 radiation standards.

Indications for Use

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

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

• Aquilion RXL, TSX-101A (K121553)

Submission Summary (Full Text)

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

October 9, 2015

Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K151833

Trade/Device Name: Aquilion Lightning (TSX-035A/2, V7.0) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 21, 2015 Received: September 22, 2015

Dear Mr. Tadeo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

# K151833

Device Name

Aquilion Lightning, TSX-035A/2, V7.0

#### Indications for Use (Describe)

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

The Aquilion Lightning 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.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### TOSHIBA AMERICA MEDICAL SYSTEMS, INC

2441 Michelle Drive, Tustin, CA 92780 Phone: [phone]

#### 510(k) SUMMARY

#### 1. SUBMITTER'S NAME:

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

### 2. OFFICIAL CORRESPONDENT:

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

# 3. ESTABLISHMENT REGISTRATION:

9614698

### 4. CONTACT PERSON:

Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 [phone]

### 5. Date Prepared:

July 2, 2015 (Updated September 17, 2015)

### 6. TRADE NAME(S):

Aquilion Lightning, TSX-035A/2, V7.0

### 7. COMMON NAME:

System, X-ray, Computed Tomography

### 8. DEVICE CLASSIFICATION:

Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)

### 9. PRODUCT CODE / DESCRIPTION:

90JAK / Computed Tomography X-Ray System

## 10. PERFORMANCE STANDARD:

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

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## 11. PREDICATE DEVICE:

| Product | Marketed by | Regulation | Regulation | Product | 510(k) | Clearance |
|---------------------------|------------------------------------|------------|--------------------------------------------|---------|---------|------------------|
| | | Number | Name | Code | Number | Date |
| Aquilion RXL,<br>TSX-101A | Toshiba America<br>Medical Systems | 892.1750 | Computed<br>Tomograph<br>y X-ray<br>System | 90JAK | K121553 | July 26,<br>2012 |

## 12. REASON FOR SUBMISSION:

New device.

# 13. DEVICE DESCRIPTION:

The Aquilion Lightning, TSX-035A/2, v7.0 is a 16-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. This system is based upon the technology and materials of previously marketed Toshiba CT systems.

# 14. INDICATIONS FOR USE:

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

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

# 15. SUBSTANTIAL EQUIVALENCE:

The Aquilion Lightning, TSX-035A/2, is substantially equivalent to the Aquilion RXL, TSX-101A, that received premarket clearance under K121553 and is marketed by Toshiba America Medical Systems. Included in this submission is a comparison table that lists the similarities and differences between the Aquilion Lightning, TSX-035A/2, and the predicate device. See below for a brief comparison of the technological characteristics between the subject and the predicate devices:

| Item | Aquilion Lightning, TSX-035A/2 | Aquilion RXL, TSX-101A |
|----------------------------|----------------------------------------|--------------------------------------|
| 510(k) Number | This submission | K121553 |
| Gantry Rotation Speed | 0.75 sec/rotation<br>(Option: 0.6 sec) | 0.5 sec/rotation<br>(Option: 0.4sec) |
| Detector | 800 channels × 16 rows | 896 channels × 16 rows |
| FOV (field of view) | 180/240/320/390/500 mm | 180/240/320/400/500 mm |
| Rated output | Max. 36 kW | Max. 60 kW (72kW*) |
| X-ray tube voltage | 80/100/120/135 kV | 80/100/120/135 kV |
| X-ray tube current | 10-300 mA | 10-500 mA |
| X-ray fan angle | 43.9° | 49.2° |
| Noise reduction processing | QDS, AIDR 3D , AIDR3D Enhanced | QDS, AIDR 3D |
| Metal Artifact Reduction | SEMAR (Helical Scan) | Not Available |

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| Gantry opening size (diameter) | 780 mm | 720 mm |
|--------------------------------|-----------------------|-----------------------|
| Tilt angle | $ \pm $ 30° | $ \pm $ 30° |
| Installation area | Minimum 17.1m² | Minimum 27m² |
| (Short patient couch) | (14.3 m²) | (25 m²) |

## 16. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the following standards IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

## 17. TESTING

Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and noise properties.

Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen, pelvis and peripheral exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

Additionally, testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

### 18. CONCLUSION

The Aquilion Lightning, TSX-035A/2, performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon bench testing, representative clinical images, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device.