(72 days)
K903701/A
Not Found
No
The device description focuses on standard CT technology (slip ring, data reconstruction, helical scanning) and explicitly states that the computer components are "mature technologies that are standard to and well known throughout the medical device industry." There is no mention of AI, ML, or related concepts in the description or the "Mentions AI, DNN, or ML" section.
No.
The device is described as an X-ray imaging device for diagnostic purposes, specifically a CT Scanner, which collects transmission data and reconstructs it into images. It does not mention any therapeutic capabilities.
Yes
The device is a CT scanner which generates images, and the 'Intended Use / Indications for Use' section explicitly states "X-ray imaging of whole body - Computerized Tomography," which is a diagnostic imaging modality.
No
The device description clearly states it is a "whole body CT Scanner" and details hardware components like an x-ray tube, x-ray detector, and computer hardware for data processing and storage.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a CT scanner that uses X-ray imaging of the whole body. It works by passing X-rays through the body and detecting the transmission data to create images.
- No Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device directly interacts with the patient's body using X-rays.
Therefore, based on the provided information, the Asteion (TSX-021A) is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Asteion (TSX-021A) is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data, as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "slice" of the body. As is common with today's CT Scanner, the Asteion has the capability to acquire volumetric (helical) data by initiating table movement during data This data can be reconstructed per the operator's preference, to include three acquisition. dimensional rendering of the patient data. Additionally the TSX-021A is capable of CT Fluoroscopy, which is used on other Toshiba CT scanners and has received previous market clearance from the Agency. This device incorporates a standard x-ray tube and a solid state x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
whole body
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): 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.
K903701/A
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
OCT 21 1998
510(k) Summary
| Date: | 5 August 1998 |
|---|---|
| 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: | Asteion CT Scanner, TSX-021A |
| Common Name: | Scanner, Computed Tomography, X-Ray JAK |
| [Fed. Reg. No. 892.1750, Pro. Code: 90JXD] | |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Predicate Device: | Toshiba TSX-011A, Xpress [K903701/A] |
| Reason For Submission | New Product |
Description of this Device:
The Asteion (TSX-021A) is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data, as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "slice" of the body. As is common with today's CT Scanner, the Asteion has the capability to acquire volumetric (helical) data by initiating table movement during data This data can be reconstructed per the operator's preference, to include three acquisition. dimensional rendering of the patient data. Additionally the TSX-021A is capable of CT Fluoroscopy, which is used on other Toshiba CT scanners and has received previous market clearance from the Agency. This device incorporates a standard x-ray tube and a solid state x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.
Summary of Intended Uses:
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image 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, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration.
1
This device employs no intended uses that are not in cleared devices already found in the marketplace.
Technological Characteristics:
This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. Both of these devices produce two dimensional, black and white image that can be filmed or electronically stored for future review.
Conformance to Standards:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Additionally this system is in conformance with the applicable parts of the following Standards:
IEC-60601 - Medical Device Safety NEMA-PS3 - DICOM Standard
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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that suggest movement and flight. The overall design is simple and clean, with a focus on the eagle as a symbol of strength and freedom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068
Re: K982787
Asteion CT Scanner. TSX-021A Dated: August 5, 1998 Received: August 10, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Biggins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Federal Food, Drug, and Cosmetic Act (Act. Xou 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 sanst 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 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (11-CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition: FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 OFR Part 801 and additionally 809:10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ____Asteion CT Scanner_TSX-021A
Indications for Use:
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gamil A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Prescription Use _ 1 (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)