(14 days)
Not Found
No
The summary describes post-processing software to extend the field of view of a CT system. There is no mention of AI, ML, training data, test data, or performance metrics typically associated with AI/ML algorithms.
No.
The device is a software option for a CT system that post-processes images to provide an extended field of view. It is stated to increase the amount of image information and allow for visualization, which indicates it is a diagnostic tool, not a therapeutic one.
Yes
The device is a software option for a CT system, which is used to generate images of the body. These images are then used by healthcare professionals to diagnose medical conditions, making the CT system and its associated software diagnostic devices. Its purpose is to "increase the amount of image information" for visualization, directly supporting the diagnostic process.
No
The device is described as a "post processing software option for the TSX-201A CT system" and requires "software modifications to the existing device." This indicates it is an add-on software component to a hardware medical device (the CT system), not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CSTC-002A software is a post-processing tool for a CT system. It manipulates and extends the field of view of images acquired by the CT scanner.
- Input: The input is image data from a CT scan, not a biological sample from the patient.
- Output: The output is an enhanced image with a larger field of view, not a diagnostic result derived from analyzing a biological sample.
The device is clearly focused on image processing and visualization for a medical imaging system (CT), which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
CSTC-002A, Extended Field of View Software is a post processing software option for the TSX-201A CT system. This product increases the amount of image information from the Large 70 cm field of view (FOV) to a 85 cm field of vicw.
Product codes (comma separated list FDA assigned to the subject device)
90JAK
Device Description
The CSTC-002A will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires software modifications to the existing device. Addition of this option will allow for visualization of the body and patient couch beyond the normal field of view.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography, X-Ray
Anatomical Site
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.
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
3rd party renew
NOV - 9 2006
510(k) Summary
| Date: | October 16, 2006 |
|---|---|
| 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: | CSTC-002A, Extended Field of View |
| Software Option | |
| 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): | Siemens Extended Field of View; K032536 |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The CSTC-002A will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires software modifications to the existing device. Addition of this option will allow for visualization of the body and patient couch beyond the normal field of view.
Summary of Intended Uses:
CSTC is intended to display the body and patient table beyond the normal field of view. Images generated by this software are not to be used for diagnostic purposes. Standard distance measurements are allowed.
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.
1
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 package provides similar tools to those found in the predicate device. This package does not provide new indications or functions when compared to those that are already available in products already being marketed.
2
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
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
NOV - 9 2006
Re: K063241
Trade/Device Name: CSTC-002A, Extended Field of View Software Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 23, 2006 Received: October 26, 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/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in the center, with the word "Centennial" underneath. Above the letters "FDA" are the numbers "1906-2006". There are three stars below the word "Centennial".
Protecting and Promoting Public Health
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualice of a becement.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a delerimiation that Journer Federal agencies. You must or any Federal Statutes and regulations admindents of the registration and listing (21 comply with all the Act s requirements, moraliantes, woulfacturing practice requirements as set a CFR Park 807); labeling (21 CFR Part 800); good will and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000 1050 forth in the quality systems (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) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket nothcation. The IDA miding of bassification 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 If you desire specific advice for your device on one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, please note the regulation childed, "Theoration on your responsibilities under (21CFR Part 607.97). Tod may other general the Free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlVindustry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: CSTC-002A, Extended Field of View Software Option
Indications For Use:
CSTC-002A, Extended Field of View Software is a post processing software option for the TSX-201A CT system. This product increases the amount of image information from the Large 70 cm field of view (FOV) to a 85 cm field of vicw.
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 __
Nancy Chaplin
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number