(45 days)
Not Found
No
The summary describes a standard multi-slice CT system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is described as a multi-slice CT system for the acquisition and display of x-ray images, which is diagnostic imaging, not therapeutic.
Yes
Explanation: The device, a CT system, acquires and displays x-ray images, which are used for diagnostic purposes by medical professionals to identify and assess medical conditions.
No
The device description explicitly states it consists of a gantry, patient couch, and console, which are hardware components of a CT system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Acquisition and display of axial x-ray images of the whole body to include the head." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description clearly states it's a "multi-slice CT system," which is a type of medical imaging equipment.
- Input Imaging Modality: The input is "x-ray transmission data," which is characteristic of imaging devices, not IVDs.
- Anatomical Site: The anatomical site is the "whole body to include the head," indicating it's used on a living patient.
IVDs, on the other hand, are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not perform such analysis on specimens.
N/A
Intended Use / Indications for Use
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities gastro intestinal lesions , abdominal and levic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, ass intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place.
Acquisition and display of axial x-ray images of the whole body to include the head.
Product codes
JAK
Device Description
The Aquilion 32/64 SP is a multi-slice CT system, consisting of a gantry, patient couch and console. The system generates uop to 128 axial images ower second using a selectable slice-thickness multi-row detector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human body (head, spine, extremities, gastro intestinal, abdominal, pelvic)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
TSX-101A/I Aquilion 64 SP CT System, Toshiba TSX-101A/H, /I Aquilion 32/64 SP CT scanner [K051833]
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) Pre-market Notification
510(k) Summary
MAR 1 4 2008
| Date: | January 25, 2008 |
|---|---|
| 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, Regulatory Affairs Specialist, |
| (714)730-5000 | |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | TSX-101A/H, Aquilion 32 SP CT System |
| TSX-101A/I, Aquilion 64 SP CT System | |
| 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-101A/I Aquilion 64 SP CT System |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The Aquilion 32/64 SP is a multi-slice CT system, consisting of a gantry, patient couch and console. The system generates uop to 128 axial images ower second using a selectable slice-thickness multi-row detector.
Summary of Intended Uses:
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities gastro intestinal lesions , abdominal and levic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, ass intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place.
1
Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification
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-101A/H, /I Aquilion 32/64 SP CT scanner [K051833].
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that appears to be a representation of human services.
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
MAR 1 4
Re: K080211
Trade/Device Name: Model TSX-101A/H, /I AQUILION 32/64 SP CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 27, 2008 Received: February 28, 2008
Dear Mr. Mark 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 circular logo or emblem. The text "1906 - 2006" is at the top of the circle. The letters "FDA" are in the center of the circle, with the word "Centennial" underneath. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.
Protecting and Promoting Public Health.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 10802
Device Name: TSX-101A/H, // Aquilion 32/64 SP CT System
Indications For Use:
Acquisition and display of axial x-ray images of the whole body to include the head.
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
Sign Off
(Division Sign-OII)
Division of Reproductive, Abdominal and Radiological 510(k) Number