(64 days)
No
The description focuses on hardware upgrades (multiple detectors) and improved image acquisition speed and resolution, with no mention of AI/ML algorithms for image processing, analysis, or other functions.
No
This device is an X-ray imaging system (CT scanner) used for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is described as an X-ray imaging system for whole-body Computerized Tomography (CT), which is a well-established diagnostic imaging modality used to visualize internal structures for medical diagnosis.
No
The device description explicitly states it is an "upgrade to previously cleared Aquilion CT Scanner" and "employs multiple solid state detectors," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "X-ray imaging of whole body - Computerized Tomography". This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details an upgrade to a CT scanner, focusing on the hardware (detectors) and methodology for acquiring images.
- Input Imaging Modality: The input is "X-ray transmission data", which is the data collected by a CT scanner.
- Anatomical Site: The anatomical site is "whole body", indicating it's used for imaging the patient directly.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device operates by directly imaging the patient's body using X-rays.
N/A
Intended Use / Indications for Use
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 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 extremittestinal 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.
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
Product codes
90JAK
Device Description
The Multislice kit is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265]. This upgrade will allow for the collection of multiple axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high resolution slices will maintaining the speed required to reduce anatomical motion artifacts.
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. This device produces two dimensional, black and white image that can be filmed or electronically stored for future review.
Mentions image processing
Not Found
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)
Reference Device(s)
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
3/19/99
510(k) Summary
K99 0134
| Date: | 11 January 1999 |
|---|---|
| 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: | Multislice Upgrade Kit for Aquilion CT Scanner, TSX-101A |
| (Aquilion/Multi) | |
| 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): | Toshiba TSX-101A, Aquilion [K982265] |
| Other Similar Devices: | Siemens SOMATOM Plus 4 with Volume Zoom [K982349] |
| Elscint Volumax CT scanner [K982060] | |
| GE LightSpeed QXi [K980176] | |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The Multislice kit is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265]. This upgrade will allow for the collection of multiple axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high resolution slices will maintaining the speed required to reduce anatomical motion artifacts.
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 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 extremittestinal 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 device 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. This device produces two dimensional, black and white image that can be filmed or electronically stored for future review.
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 - Medical Device Safety standards.
Substantial Equivalence:
Based upon the above considerations TAMS believes that this upgrade package. Multislice CT, CGS-22A, is substantially equivalent to the Aquilion CT scanner. Other devices on the market that share the characteristics of this device are the Siemens SOMATOM Plus 4 with Volume Zoom [K982349], the Elscint Volumax CT scanner [K982060], and the GE LightSpeed QXi [K980176].
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus in the logo is depicted with three intertwined strands and a single wing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1999
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Dr. P.O. Box 2068 Tustin, CA 92781
Re:
K990134 Multislice Upgrade Kit for Aquilion CT Scanner Dated: January 11, 1999 Received: January 14, 1999 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Madical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 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 CFR 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
11 99 0134 510(k) Number (if known): _
Multislice Upgrade kit (CGS-22A) for the Aquilion CT Scanner TSX-101A Device Name:
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)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Kyanı 24 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)