(15 days)
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Not Found
No
The summary describes a hardware upgrade to a CT scanner focused on increasing the number of slices acquired. There is no mention of AI/ML in the device description, intended use, or any other section.
No
The primary function of this device is X-ray imaging for diagnostic purposes (Computerized Tomography), not for treating medical conditions. It upgrades a CT scanner to improve image acquisition, which is a diagnostic capability.
Yes
The device is described as an "X-ray imaging of whole body - Computerized Tomography" system, which is a common diagnostic imaging modality used to visualize internal structures for the purpose of diagnosis.
No
The device description explicitly states it is an "upgrade to previously cleared CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner" and mentions the use of "multiple solid state detectors," indicating it is a hardware upgrade to a CT scanner, not a software-only device.
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 in vivo imaging procedure, meaning it's performed on a living organism (the patient).
- Device Description: The description details a CT scanner upgrade that collects X-ray data from the patient's body. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to be used outside the body to examine these types of samples.
Therefore, this device falls under the category of medical imaging devices used for diagnostic purposes in vivo.
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 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. This device employs no intended uses that are not in cleared devices already found in the marketplace.
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)
90JAK
Device Description
The Multislice kit is an upgrade to previously cleared CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner [K020385]. This upgrade will allow for the collection of sixteen axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high-resolution slices while maintaining the speed required to reduce anatomical motion artifacts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray transmission data
Anatomical Site
human body
spine
head
brain
eyes
extremities
gastrointestinal
abdominal
pelvic
hepatic
musculoskeletal
Indicated Patient Age Range
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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.
CGS-30A Multislice Upgrade kit for the Aquilion CT
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
Jul 9 2002
510(k) Summary
×022056
| Date: | June 5, 2002 |
|---|---|
| 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 Manager, (714)730-5000 |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner |
| TSX-101A(Aquilion Advance 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): | CGS-30A Multislice Upgrade kit for the Aquilion CT |
| Reason For Submission | Modification of cleared device |
· Description of this Device:
The Multislice kit is an upgrade to previously cleared CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner [K020385]. This upgrade will allow for the collection of sixteen axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high-resolution slices while maintaining the speed required to reduce anatomical motion artifacts.
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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 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. This device employs no intended uses that are not in cleared devices already found in the marketplace.
Technological Characteristics:
1
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 and three dimensional, black and white images 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-31A, is substantially equivalent to the CGS-30A upgrade kit for Aquilion CT scanner. The major difference is the number of slices being collected in a single rotation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.
Toshiba America Medical Systems, Inc. Re: K022050 % Mr. Mark Job Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Trade/Device Name: CGS-31A Multislice Upgrade kit for Aquilion CT Scanner Model TSX-101A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: June 21, 2002 Received: June 24, 2002
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 (PMA). it may be subject to 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.
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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Henry 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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Multislice Upgrade kit (CGS-31A) 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) | David G. |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K022050 |
Prescription Use ____________ OR ____________ Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
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