(86 days)
No
The summary describes a hardware system for acquiring transmission CT data and performing attenuation corrections on SPECT images. There is no mention of AI, ML, or any advanced image processing techniques that would typically involve these technologies.
No
Explanation: The device is described as an imaging system used to acquire transmission CT data and generate attenuation maps for SPECT images, which are diagnostic functions, not therapeutic.
No
The device is described as an "option designed to be used with Toshiba's GCA-7200 gamma camera systems to acquire transmission CT data (TCT)." Its function is to "generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images." It is fundamentally an accessory or component for an imaging system (gamma camera) that helps to refine the images by correcting for attenuation, rather than directly detecting or diagnosing a disease state itself. The "Intended Use" states it is "To detect or image the distribution of radionuclides in the body or organ," which points to an imaging function. While imaging can be used for diagnosis, this device's specific role is about image correction within a broader imaging system, not the diagnostic interpretation.
No
The device description explicitly states it is a "Transmission system, model NDTR-701A" and is an "option designed to be used with Toshiba's GCA-7200 gamma camera systems to acquire transmission CT data (TCT)." It also mentions an "external flood source" and a "parallel-hole collimator," which are hardware components. Therefore, it is not a software-only 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 description clearly states the device is used to "detect or image the distribution of radionuclides in the body or organ" using SPECT and Transmission CT. This is an in vivo imaging technique, meaning it's performed on a living organism, not on a sample outside the body.
- Intended Use: The intended use is for imaging and attenuation correction within the body, not for analyzing biological samples.
Therefore, the TRANSVIEW (Transmission system), model NDTR-701A, is a medical imaging device, specifically a component for a gamma camera system, and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The purpose of this option is to provide non-uniform attenuation correction, simultaneously or sequentially, using a uncollimated sheet line source and a parallel-hole collimator. Toshiba America Medical Systems, Inc. believes that this device is safe and effective in that it offers no new intended uses that are not in use on existing marketed devices.
Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
Nuclear Medicine Device
Tomographic imaging (SPECT) for non Positron emitter
Energy Range (keV) 50-400
Product codes
90 KPS
Device Description
The TRANSVIEW (Transmission system), model NDTR-701A is an option designed to be used with Toshiba's GCA-7200 gamma camera systems to acquire transmission CT data (TCT). When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma camera systems (Transmission CT data (TCT)), SPECT
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
ADAC Vantage (K943596), Picker STEP 2000 Option (K960865), Siemens E CAM Profile (K963983), Elscint TransACT (K952674)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
SEP 2 5 1998
510(k) Summary
| Date: | June 15, 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: | Donelle Krajewski, Regulatory Affairs Specialist, |
| (714)730-5000, Extension 4121 | |
| Device Proprietary Name: | TRANSVIEW (Transmission System), Model NDTR-701A |
| Classification Name: | Emission Computed Tomography System |
| Common Name: | Gamma Camera Option |
| [Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] | |
| Predicate Devices: | ADAC Vantage (K943596), Picker STEP 2000 Option |
| (K960865), Siemens E CAM Profile (K963983), and | |
| Elscint TransACT (K952674) | |
| Reason for Submission | New option for existing product |
Description of this Device:
The TRANSVIEW (Transmission system), model NDTR-701A is an option designed to be used with Toshiba's GCA-7200 gamma camera systems to acquire transmission CT data (TCT). When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.
Summary of Intended Uses:
The purpose of this option is to provide non-uniform attenuation correction, simultaneously or sequentially, using a uncollimated sheet line source and a parallel-hole collimator. Toshiba America Medical Systems, Inc. believes that this device is safe and effective in that it offers no new intended uses that are not in use on existing marketed devices.
Technological Characteristics:
This device employs the same technological characteristics as the predicate devices, differing only in the specifics of subassembly component composition and algorithms used. All systems employ the use of a transmission source to provide the attenuation map. This attenuation map is then used to perform attenuation corrections on SPECT images along with scatter correction. Non uniform attenuation correction using transmission systems is well understood and is documented in peer reviewed scientific publications.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
SEP 2 5 1998
Donelle Kajewski Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781
Re:
K982300 TransView (Transmission System), Model NDTR-701A Dated: June 15, 1998 Received: July 1, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Kajewski:
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 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, against. misbranding and adulteration.
If your device is classified (see above) into either class II (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 (OS) for Medical Devices: General regulation (2) 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 predication 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 vite 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/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
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
2
RECEIV ¯
APR 2 4 1998
Page____ of ____
:
REGULATORY AFFAIR®
| 510(k) Number (if known): | and and and the results of the cases of the |
|---|---|
| --------------------------- | --------------------------------------------- |
Device Name: JRAN'S UIEW WEW _________________________________________________________________________________________________________________________________________________
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… ここに… …
i
Nuclear Medicine Device
Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
| XES | ಗರ | Energy Range (keV) | |
|---|---|---|---|
| 4 | |||
| Planar imaging | |||
| A. | X | ||
| Whole body imaging | |||
| B. | |||
| C. | |||
| Tomographic imaging (SPECT) | |||
| for non Positron emitter | × | 50-400 | |
| D. | |||
| Positron imaging by coincidence | × | ||
| Positron imaging without coincidence | |||
| E. | |||
| F. | |||
| Other indication(s) in the device label, | |||
| but not included in above list | ース アニメーカー アイト アパート アイト アイト アイト アイト アイト アイト アイ | ||
| ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー | |||
| (Please do not write below this line - Continue on another page if needed) | |||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
| Prescription Use______________________________________________________________________________________________________________________________________________________________ | |||
| OR | |||
| (Per 21 CFR 801.109) | |||
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, ENT, | |||
| and Radiological Devices | |||
| 510(k) Number . | Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ | ||
| (Optional Format 1-2-96) |