(29 days)
K110066, k10066
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard CT technology and image acquisition.
No
The device is a CT system used for acquiring and displaying images for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The device is a CT system that acquires and displays cross-sectional volumes of the whole body, which are then used by a trained and qualified physician to perform specialized studies. This process is inherently diagnostic, as it involves capturing data used to identify diseases or conditions.
No
The device description explicitly states it is a "40-row CT System," which is a hardware device. While it mentions the use of "indicated software/hardware" for specialized studies, the core device itself is a physical CT scanner.
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.
- Device Function: The description clearly states the device is a CT System used to acquire and display cross-sectional volumes of the whole body. This is an imaging modality that works by sending X-rays through the body and detecting how they are absorbed, not by analyzing samples taken from the body.
- Intended Use: The intended use is for acquiring and displaying images for diagnostic purposes, which is characteristic of medical imaging devices, not IVDs.
Therefore, this device falls under the category of a medical imaging device, not 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 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.
Product codes
JAK, IYO, ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
whole body, to include the head.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Toshiba TSX-302A, K110066, Toshiba Aquilion PRIME TSX-302A; k10066
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. 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)
(714)730-5000
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 (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 Division 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. 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
| (Part 21 CFR 801 Subpart D) | ✓ |
|---|---|
| AND/OR Over-The-Counter Use | |
| (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
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