(14 days)
Not Found
No
The summary describes a respiratory gating option for a CT system, focusing on hardware and software modifications for acquiring and displaying images based on the respiratory cycle. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is used for imaging (diagnosis), not for treating a disease or condition. The text clearly states "X-ray imaging of whole body - Computerized Tomography".
Yes
This device is an X-ray imaging system (CT) for the whole body, which is a diagnostic imaging modality used to evaluate anatomical structures and identify abnormalities for medical diagnosis. The "Respiratory Gated (4D) Scanning" feature further enhances its diagnostic capabilities by allowing the evaluation of respiration-induced motion.
No
The device description explicitly states that the addition requires "hardware and software modifications to the existing device," indicating it is not software-only.
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 provided description clearly states the device is an X-ray imaging system (Computerized Tomography) used for imaging the whole body. It acquires images by transmitting X-rays through the body.
- 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 to generate images.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
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, 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. Additionally this device will employ respiratory gating to reduce motion artifacts and improve targeting of anatomy for use with other cleared devices. 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 Respiratory (4D) Gated Scanning
Respiratory Gated (4D) Scanning on the Aquilion LB is a non-invasive software/hardware option that can be used for the evaluation of respiration-induced motion by acquiring and displaying CT images consisting of all respiratory phases during a breathing cycle
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The CKRS-003A Respiratory Gating Option will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires hardware and software modifications to the existing device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray transmission data
Anatomical Site
human body (spine, head, brain, eye, extremities, gastrointestinal tract, abdomen, pelvis, liver, intestines, musculoskeletal)
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.
TSX-201A Aquilion LB K050458, Varian HPM K983629
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
MAY 12 2005
510(k) Summary
| Date: | April 10, 2005 |
|---|---|
| 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: | |
| (714)730-5000 | Paul Biggins, Regulatory Affairs Specialist, |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | TSX-201A Aquilion LB with Respiratory |
| Gating | |
| Common Name: | |
| 90JAK] | Scanner, Computed Tomography, X-Ray |
| [Fed. Reg. No. 892.1750, Pro. Code: | |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard: | |
| Standard | 21 CFR Subchapter J, |
| Federal Diagnostic X-ray Equipment | |
| Predicate Device(s): | TSX-201A Aquilion LB K050458 |
| Varian HPM K983629 | |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The CKRS-003A Respiratory Gating Option will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires hardware and software modifications to the existing device.
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, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to
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K06 US87
Page 2 of 2
examine musculoskeletal degeneration. Additionally this device will employ respiratory gating to reduce motion artifacts and improve targeting of anatomy for use with other cleared devices. This device employs no intended uses that are not in cleared devices already found in the marketplace.
Technological Characteristics:
This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results.
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:
Toshiba TSX-201A, Aquilion LB CT cleared via K050458 Varian RPM Respiratory Gating System cleared via K983629
Toshiba America Medical Systems, Inc. believes that the combination of the two devices does not change the intended use of either device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, with flowing lines suggesting movement or support.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 1 2 2006
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K061187
Trade/Device Name: Toshiba TSX-201A, Aquilion LB CT System with Respiratory Gating (CKRS-003A)
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 25, 2006 Received: April 28, 2006
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/12 description: The image is a black and white logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with the letters "FDA" in a bold, sans-serif font in the center. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged below the word "Centennial". The outer ring of the logo contains text and star symbols.
Preventing 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 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
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
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
K661187
Device Name: Toshiba TSX-201A, Aquilion LB CT System with Respiratory Gating (CKRS-003A
Indications for Use:
X-ray imaging of whole body - Computerized Tomography Including;
Axial Volumetric (Helical) CT Fluoroscopy Respiratory (4D) Gated Scanning
Respiratory Gated (4D) Scanning on the Aquilion LB is a non-invasive software/hardware option that can be used for the evaluation of respiration-induced motion by acquiring and displaying CT images consisting of all respiratory phases during a breathing cycle
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR§801.109)
Over-The-Counter Use
(Optional Format 1-2-96) Division Sign-Off) Division of Reproductive, Abdominal.
OR
and Radiological D C4 M-1 M-1 M-1 M-1