(290 days)
K931297/A
K931297/A
No
The description details a deterministic scatter correction method (Triple Energy Window) and does not mention AI/ML terms or concepts.
No
The device is described as an optional software program for gamma camera systems that processes image data to remove scatter. It does not exert any direct therapeutic effect on a patient.
No
Explanation: The device is described as an optional software program for gamma camera systems that processes acquired scatter data to remove it from image data. Its intended use is described in the context of improving gamma camera applications, which are primarily for imaging rather than direct diagnosis. The software itself performs image processing to enhance image quality, but it does not independently provide a medical diagnosis or diagnostic information.
Yes
The device is described as an "optional software program" for existing gamma camera devices and its function is solely image processing (scatter correction). There is no mention of any new hardware components being introduced or modified.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "all traditional and accepted gamma camera applications," primarily for acquiring and processing tomographic studies. This is related to medical imaging and diagnosis based on the distribution of radioactive tracers within the body, not the analysis of samples taken from the body (which is the core of IVD).
- Device Description: The device is software that processes image data acquired by a gamma camera. It performs scatter correction on the image data. This is an image processing function, not a diagnostic test performed on a biological sample.
- No Mention of Biological Samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device operates on image data generated by a gamma camera, which is a different type of diagnostic tool.
N/A
Intended Use / Indications for Use
This program can be utilized for all traditional and accepted gamma camera applications. It is expected that its benefits will be realized primarily when the system is being used to acquire tomographic studies. The intended use of the gamma camera system is unchanged by this program. Toshiba believes that users will find the T.E.W method to be beneficial when performing dual-nuclide acquisitions, by enhancing the system's ability to detect the energy peaks of each nuclide without interference from the other nuclide. This determination is left to the user, however, and no specific claims regarding dual nuclide uses are being made. Due to the absence of new intended uses, it follows that the overall safety and effectiveness of the gamma camera system is not changed by this program.
Product codes
Not Found
Device Description
This product is an optional software program available for the Toshiba DI-series devices. It is intended to give a user the ability to acquire scatter data during acquisitions, then remove the unwanted scatter data from the processed image data. Based on the Triple Energy Window method of Compton - Scatter Correction, this program calculates the location and amount of scatter data in each pixel and subtracts it from the patient data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Gamma Camera
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)
[K931297](https://510k.innolitics.com/search/K931297)/A
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
DEC 23 1996
510(k) Summary
17960948
Javad Sevedzadeh. Director of Regulatory Affairs Submitted by: Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92681 Tel .: 714-730-5000 Contact: Mark Stauffer. Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. Tel.: 714-730-5000
Date:
March 6, 1996
· Device Name
Scatter Correction Volume Software for Toshiba Gamma Cameras, Model NSSC-020A
Common name: Gamma Camera Processing Software
Classification name: Emission Computed Tomography System
· Predicate Device
Toshiba GCA-7200A (K931297/A)
· Description of Device
This product is an optional software program available for the Toshiba DI-series devices. It is intended to give a user the ability to acquire scatter data during acquisitions, then remove the unwanted scatter data from the processed image data. Based on the Triple Energy Window method of Compton - Scatter Correction, this program calculates the location and amount of scatter data in each pixel and subtracts it from the patient data.
· Intended Uses
This program can be utilized for all traditional and accepted gamma camera applications. It is expected that its benefits will be realized primarily when the system is being used to acquire tomographic studies. The intended use of the gamma camera system is unchanged by this program. Toshiba believes that users will find the T.E.W method to be beneficial when performing dual-nuclide acquisitions, by enhancing the system's ability to detect the energy peaks of each
1
nuclide without interference from the other nuclide. This determination is left to the user, however, and no specific claims regarding dual nuclide uses are being made. Due to the absence of new intended uses, it follows that the overall safety and effectiveness of the gamma camera system is not changed by this program.
• Comparison of technological characteristics
There is no change to the technology of the host device when the optional program Scatter Correction Volume, or T.E.W., is applied. This product is computational only and does not affect the physical characteristics of the host device. Determination of and correction for Comptonscatter effects are well understood and documented in peer-reviewed scientific publications.