(15 days)
TSX-301A Aquilion ONECT System
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or intended use.
No
The device is described as a CT scanner for acquiring and displaying cross-sectional volumes for diagnostic purposes, not for treating conditions.
Yes
Justification: The device's intended use is to acquire and display cross-sectional volumes of the body and organs, which are then used by a "trained and qualified physician" to perform "specialized studies." This process of acquiring imaging data for a physician to study an organ strongly indicates its use in aiding diagnosis.
No
The device description explicitly states it is a "whole body CT scanner" and lists hardware components like a gantry, patient couch, and peripheral cabinets. This indicates it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is a CT scanner, which is an in vivo imaging device. It acquires images of the inside of the body directly from the patient.
The description clearly states that the device acquires and displays cross-sectional volumes of the whole body and organs. This is the function of a medical imaging device, not an IVD.
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 then be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The TSX-301A/2 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
Computed Tomography, X-Ray
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 professional, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TSX-301A Aquilion ONECT System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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) Pre-market Notification; Aquilion ONE TSX-301A/2
510(k) Summary
| OCT 2` 2007 | ||
|---|---|---|
| Date: | September 12, 2007 | |
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, | |
| Tustin, CA 92781-2068 | ||
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs | |
| (714)730-5000 | ||
| Establishment Registration | ||
| Number: | 2020563 | |
| Device Proprietary Name: | TSX-301A/1, Aquilion ONE CT System, K063189 | |
| TSX-101A/h, /I Aquilion 32/64 SP CT System, | ||
| K051833 | ||
| Common Name: | Scanner, Computed Tomography, X-Ray | |
| [Fed. Reg. No. 892.1750, Pro. Code: 90JAK] | ||
| Regulatory Class: | II (per 21 CFR 892.1750) | |
| Performance Standard: | 21 CFR Subchapter J, | |
| Federal Diagnostic X-ray Equipment Standard | ||
| Predicate Device(s): | TSX-301A Aquilion ONECT System | |
| Reason For Submission | Modification to existing device |
Description of this Device:
The TSX-301A/2 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.
Summary of Intended Uses:
This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
1
Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; Aquilion ONE TSX-301A/2
Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate cross sectional images of the anatomy.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-44. - Medical Device Safety standards.
Substantial Equivalence:
This device is similar in materials and processes to that of the predicate device, Toshiba TSX-301A Aquilion ONE CT scanner.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
2007
Re: K072606
Trade/Device Name: TSX-301A/2, Aquilion ONE CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 14, 2007 Received: September 17, 2007
Dear Mr. Job:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a large, bold font. Below the letters, the word "Centennial" is written in a smaller font. Three stars are located at the bottom of the logo.
Proscions and Promoting Public Statte
3
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); 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.
This letter will allow you to 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for TSX-301A/2 Aquilion ONE CT System
Indications for Use
510{k) Number (if known):
Device Name: TSX-301A/2, Aquilion ONE CT System
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 then be used to perform specialized studies, using indicated software/hardware, of the whole organ 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
Tomu M. Whing
fon Sign-Off) Division of Reproductive, AbdomInal and Radiological Devices 510(k) Number