(66 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI/ML, such as automated detection, segmentation, or analysis driven by learned algorithms. The description focuses on the device's capability to acquire and display volume data sets and perform specialized studies using indicated software/hardware, which is standard for CT systems.
No.
The device is described as a CT scanner indicated for acquiring and displaying cross-sectional volumes of the body for diagnostic purposes, not for treating conditions.
Yes
The device acquires and displays cross-sectional volumes of the body and whole organs, which are then used by a trained and qualified physician to perform specialized studies, indicating its role in generating data for diagnosis.
No
The device description explicitly states it is a whole body CT scanner consisting of a gantry, patient couch, and peripheral cabinets, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description: The description clearly states the device is a "whole body CT scanner." CT scanners acquire images of the inside of the body using X-rays. This is an in vivo (within the living body) imaging modality.
- Intended Use: The intended use is to "acquire and display cross sectional volumes of the whole body." This involves imaging the patient directly, not analyzing samples taken from the patient.
Therefore, the function and operation of this device fall under the category of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This device is indicated to acquire and display cross sectional volumes of the whole body, to include 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.
Product codes
JAK
Device Description
The Aquilion ONE Vision, TSX-301C/1, v4.90 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
whole body, to include the head. Whole organs include but are not limited to brain, heart, pancreas, etc.
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
Not Found
Summary of Performance Studies
Image Quality metrics utilizing phantoms are provided in 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.
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.
0
Toshiba America Medical Systems, Inc.
510 (k) Premarket I Aquilion ONE Vision, TSX-301C/1, v4.90
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
ご
-
- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
-
- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
-
- ESTABLISHMENT REGISTRATION: 2020563
4. CONTACT PERSON:
Paul Biggins Director, Regulatory Affairs (714) 730-5000
-
- Date Prepared: July 12, 2012
-
- TRADE NAME(S): Aquilion ONE Vision, TSX-301C/1, v4.90
-
- COMMON NAME: System, X-ray, Computed, Tomography
-
- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
-
- PRODUCT CODE / DESCRIPTION: JAK - System, Computed Tomography
10. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
-
- PREDICATE DEVICE: Aquilion ONE TSX-301A/2, w/4.74ER K113466 Toshiba America Medical Systems, Inc.
12. REASON FOR SUBMISSION: Modification of a cleared device
SEP
21 2012
Page 1 of 3
1
13. DEVICE DESCRIPTION:
The Aquilion ONE Vision, TSX-301C/1, v4.90 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
14. SUMMARY OF INTENDED USES:
This device is indicated to acquire and display cross sectional volumes of the whole body, to include 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:
This device is substantially equivalent to the Aquilion ONE, TSX-301A/2, w4.74ER, K113466, marketed by Toshiba America Medical Systems. The Aquilion ONE Vision, TSX-301C/1. v4.90, includes modifications to the cleared device which improve the scan time and view rates. The method of operation, base software and manufacturing process remain unchanged from the cleared device.
| ltem | Aquilion ONE Vision, TSX-301C/1 | Aquilion ONE TSX-301A/2 |
|---|---|---|
| Gantry Rotational Speed | 0.275 Seconds | 0.35 Seconds |
| View Rate | ||
| (number of views | ||
| transferred per second) | 2910 | 2572 |
| X-ray Generator Output | ||
| Power | 90kW Maximum | 70kW Maximum |
| X-ray Tube angle | 10 degrees | 11 degrees |
| Computer System | Quad Core Xeon based | Dual Core Xeon based |
| Image reconstruction | ||
| (maximum speed) | 50 images per second | 30 images per second |
| Gantry Opening | 780mm | 720mm |
Summary of Changes from Aquilion ONE TSX-301A/2
-
- Increased rotational speed from 350mS to 275mS
-
- X-ray Generator is changed to match dose at new speed
-
- Tube has hardware enhancements to allow for higher rotational speed
-
- View rates have been increased
Page 2 of 3
2
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 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 product report.
17. TESTING
Image Quality metrics utilizing phantoms are provided in 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.
18. CONCLUSION
The modifications incorporated into the Aquilion ONE Vision, TSX-301C/1, v4.90 do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications.
3
Image /page/3/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.
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 % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
SEP 21 2012
Re: K122109
Trade/Device Name: Aquilion ONE Vision, TSX-301c/1, v4.90 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 16, 2012 Received: July 17, 2012
Dear Mr. Biggins:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premains is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Citiestic) to tegans mannent date of the Medical Device Amendments, or to Conimeres prior to May 20, 1978, the eccordance with the provisions of the Federal Food, DINA de vices mat have occh rechasinou in actre approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierefore, market the device, boode requirements for annual registration, listing of general controls provisions of the fiel 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 IT your device is Classified (see above) interest affecting your device can be found in Title 21, additional contors. Existing mayor regulations of the 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 Please be auvised that FDA s issuation of a succession in ther requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a determination that your as read by other Federal agencies. You must of any Federal statutes and regulations ammitted to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related adverses vrelity systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the quality of evice as described in your Section 510(k) premarket witi anow you to begin mainential equivalence of your device to a legally marketed nontication. The I Dry intellig of cassion 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 If you desire specific ad rior to: your its a vice Evaluation and Safety at (301) 796-5450. 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours, Janine M. Mon
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Aquilion ONE Vision, TSX-301C/1, v4.90
Indications for Use:
This device is indicated to acquire and display cross sectional volumes of the whole body, to include 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Sian-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K122109