(381 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as an "80-row CT System that is intended to produce axial scans of the whole body to include the head," indicating it is used for diagnostic imaging rather than therapy.
Yes
Explanation: The device is a CT system that acquires and displays cross-sectional volumes of the whole body, which is a common function of diagnostic imaging devices used by physicians to diagnose medical conditions.
No
The device description explicitly states it is an "80-row CT System," which is a hardware device. The software mentioned is used to process the data acquired by this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used to "acquire and display cross-sectional volumes of the whole body, to include the head." This is a description of an imaging device used for diagnostic purposes on the patient's body, not on samples taken from the body.
- Device Description: The device is described as an "80-row CT System" that produces "axial scans of the whole body." This further confirms it's an imaging device.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by scanning the patient directly.
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 then be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician."
Product codes
JAK
Device Description
"The TSX-302A is an 80-row CT System that is intended to produce axial scans of the whole body to include the head. The TSX-302A 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
Computed Tomography, X-Ray
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Toshiba TSX-301A/2, K093891
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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JAN 2 6 2012
Section 5. 510(k) Summary
| Date: | December 22, 2010 |
|---|---|
| Manufacturer: | Toshiba Medical Systems Corporation |
| 1385 Shimoishigami, Otawara-shi, | |
| Tochigi-ken, 324-8550, Japan | |
| Initial Importer/Distributor: | |
| Address: | |
| Contact: | Toshiba America Medical Systems, Inc. |
| P.O. Box 2068, 2441 Michelle Drive, | |
| Tustin, CA 92781-2068 | |
| Paul Biggins, Director Regulatory Affairs | |
| (714)730-5000 | |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | TSX-302A, Aquilion Prime |
| Common Name: | Scanner, Computed Tomography, X-Ray |
| Classification: | 90-JAK |
| Regulatory Class: | Il (per 21 CFR 892.1750) |
| Performance Standard: | None |
| Predicate Device(s): | Toshiba TSX-301A/2, K093891 |
Reason for Submission New Device
Description of this Device:
The TSX-302A is an 80-row CT System that is intended to produce axial scans of the whole body to include the head. The TSX-302A is based upon the technology and materials of previously marketed Toshiba CT systems.
1
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 ONE TSX-301A/2; K093891
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 eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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. P.O. Box 2068, 2441 Michelle Drive TUSTIN CA 92781-2068
JAN 2 6 2012
Re: K110066
Trade/Device Name: TSX-302A, Aquilion Prime CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 13, 2011 Received: December 14, 2011
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
3
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 will allow you to begin marketing your device as described in your Section 510(k) premarket writication. 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,
Mary S Patel
Mary S. Pastel, Sc.D. 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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Indications for Use
510(k) Number (if known): _
Device Name: . TSX-302A, 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mary Stott
(Division Sign-Off)
Division of Radiological Office of In Vitro Diagnost
510K. K110066