(189 days)
Not Found
Unknown
While the document mentions advanced image processing techniques like AIDR 3D Enhanced and Metal artifact reduction, it does not explicitly state that these or any other features utilize AI or ML. The description of performance studies focuses on traditional image quality metrics and comparisons to manual measurements, without mentioning AI/ML-specific evaluation methods.
No.
The device is a whole body CT scanner, which is an imaging device used for diagnosis, not for treating or rehabilitating a medical condition.
Yes
The device is a whole body CT scanner that acquires and displays cross-sectional volumes of the head and organs, which are used by trained physicians to perform "specialized studies" and "clinical evaluations" for "4D Orthopedic Analysis and 4D Cerebral Artery Morphological Analysis," indicating its use in diagnosing conditions.
No
The device description explicitly states it is a "whole body CT scanner" and mentions "indicated software/hardware," indicating it includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is a CT scanner that acquires images of the inside of the body directly.
- The intended use and device description clearly state that it acquires and displays cross-sectional volumes of the head and whole organs. This is an in-vivo imaging process, not an in-vitro diagnostic test.
- The device description mentions image processing and features related to image acquisition and quality (AIDR 3D, Metal artifact reduction, SurekV, SEMAR). These are typical features of medical imaging devices, not IVDs.
- The performance studies focus on image quality metrics (spatial resolution, CT number, contrast-to-noise ratio, noise properties) and the performance of image analysis applications. This aligns with the evaluation of an imaging device.
In summary, the Aquilion ONE is a medical imaging device (specifically a CT scanner) used for diagnostic purposes by visualizing internal structures of the body. It does not perform tests on samples taken from the body, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is indicated to acquire and display cross sectional volumes of the whole the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician.
Product codes
JAK
Device Description
The Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 are whole body CT scanners that capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray
Anatomical Site
whole the head, whole organs (including but not limited to brain, heart, pancreas)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing was conducted utilizing phantoms to demonstrate that the image quality metric of AIDR 3D Enhanced versus current AIDR 3D is substantially equivalent to or better than the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio, noise properties and standard deviation of noise. Bench studies were also conducted to confirm that the SurekV feature selects the appropriate kV, to confirm that SEMAR functions similarly, with regard to image quality, when used in Volume and in Helical scan modes and that applicable configurations utilizing the "UREVision detector demonstrate improved noise reduction. Additionally, clinical evaluations were conducted to demonstrate that the new applications 4D Orthopedic Analysis and 4D Cerebral Artery Morphological Analysis, perform as intended. The results confirmed that the applications were comparable to manual measurements and/or segmentations.
Summary of Performance Studies
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the requirements for the modifications made to the system have been met. The modified system was evaluated, utilizing phantoms, to demonstrate that the image quality metric of AIDR 3D Enhanced versus current AIDR 3D is substantially equivalent to or better than the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio, noise properties and standard deviation of noise. Bench studies were also conducted to confirm that the SurekV feature selects the appropriate kV, to confirm that SEMAR functions similarly, with regard to image quality, when used in Volume and in Helical scan modes and that applicable configurations utilizing the "UREVision detector demonstrate improved noise reduction. Additionally, clinical evaluations were conducted to demonstrate that the new applications 4D Orthopedic Analysis and 4D Cerebral Artery Morphological Analysis, perform as intended. The results confirmed that the applications were comparable to manual measurements and/or segmentations.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2015
Toshiba Medical Systems Corporation % Mr. Orlando Tadeo, Jr. Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780
Re: K142465
Trade/Device Name: Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 9, 2015 Received: February 11, 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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting 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) K142465
Device Name
Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0
Indications for Use (Describe)
This device is indicated to acquire and display cross sectional volumes of the whole the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
-
- SUBMITTER'S NAME:
Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
- SUBMITTER'S NAME:
2. OFFICIAL CORRESPONDENT:
Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance
-
- ESTABLISHMENT REGISTRATION: 9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
-
- Date Prepared:
February 9, 2015
- Date Prepared:
-
- TRADE NAME(S): Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, 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 DEVICES:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Aquilion ONE Vision, TSX- | |||
| 301C/1 and 301C/2, v6.00 | Toshiba America Medical Systems | K132222 | November 7, 2013 |
| Aquilion ONE Vision, TSX- | |||
| 301C/3, 301C/4 and 301C/5, | |||
| v6.00 | Toshiba America Medical Systems | K133497 | February 10, 2014 |
12. REASON FOR SUBMISSION:
Modification of a cleared device
13. DEVICE DESCRIPTION:
The Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 are whole body CT scanners that capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. These systems are 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 the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
15. SUBSTANTIAL EQUIVALENCE:
The Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 is substantially equivalent to Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00 and Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00, which were cleared via Pre-Market Notification 510(k), K132222 and K133497, respectively. The Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0, incorporates modifications to the cleared device which include a new AIDR 3D selection (AIDR 3D Enhanced), the introduction of two new clinical applications, the availability of Single Energy Metal Artifact Reduction in Helical scan mode, the addition of SurekV with SURE Exposure 3D and scan protocol management. The method of operation and manufacturing process of the CT system remain unchanged from the cleared device.
| Item | Aquilion ONE Vision,
TSX-301C/1, /2, /3,
/4, /5, /6, /7, /8, v7.0 | Aquilion ONE
Vision
TSX-301C/1, /2
v6.00 | Aquilion ONE Vision
TSX-301C/3, /4, /5,
v6.00 | Comments |
|-------------------------------|-------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------|-----------------------------------|
| 510(k) Number | This submission | K132222 | K133497 | |
| Noise reduction
processing | AIDR 3D
AIDR 3D Enhanced | AIDR 3D | AIDR 3D | New selection
added (Enhanced) |
| Metal artifact
reduction | Volume Scan
Helical Scan | Volume Scan | Volume Scan | Helical scan
added |
A complete comparison table is included in this submission. See below for a brief summary of changes:
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| ltem | Aquilion ONE Vision,
TSX-301C/1, /2, /3,
/4, /5, /6, /7, /8, v7.0 | Aquilion ONE
Vision
TSX-301C/1, /2
v6.00 | Aquilion ONE Vision
TSX-301C/3, /4, /5,
v6.00 | Comments |
|-------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------|--------------------------------|
| Dose modulation | SURE Exposure 3D
Sure kV | SURE Exposure 3D | SURE Exposure 3D | Feature
enhancement |
| 4D Orthopedic
Analysis | Optional | N/A | N/A | New application |
| 4D Cerebral Artery
Morphological
Analysis | Optional | N/A | N/A | New application |
| Detector | Up to 10% noise
reduction * | N/A | Up to 10% noise
reduction * | * Applicable
configurations |
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 IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-1-9, 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 requirements for the modifications made to the system have been met. The modified system was evaluated, utilizing phantoms, to demonstrate that the image quality metric of AIDR 3D Enhanced versus current AIDR 3D is substantially equivalent to or better than the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio, noise properties and standard deviation of noise. Bench studies were also conducted to confirm that the SurekV feature selects the appropriate kV, to confirm that SEMAR functions similarly, with regard to image quality, when used in Volume and in Helical scan modes and that applicable configurations utilizing the "UREVision detector demonstrate improved noise reduction.
Additionally, clinical evaluations were conducted to demonstrate that the new applications 4D Orthopedic Analysis and 4D Cerebral Artery Morphological Analysis, perform as intended. The results confirmed that the applications were comparable to manual measurements and/or segmentations.
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 modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.
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18. CONCLUSION
The modifications incorporated into the Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 do not change the indications for use or the intended use of the device. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.