Who is the manufacturer of SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A?

Toshiba Medical Systems filed the 510(k) submission for SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A (K960948).

What is the FDA product code for SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A

K960948 · Toshiba Medical Systems · KPS · Dec 23, 1996 · Radiology

Device Facts

Record ID	K960948
Device Name	SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
Applicant	Toshiba Medical Systems
Product Code	KPS · Radiology
Decision Date	Dec 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2

Intended 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.

Device Story

Optional software for Toshiba DI-series gamma cameras; performs Compton-scatter correction on acquired image data. Uses Triple Energy Window (T.E.W.) method to calculate scatter location and intensity per pixel; subtracts scatter from patient data. Operated by clinicians/technicians in clinical settings. Enhances image quality by reducing scatter interference, particularly useful in dual-nuclide acquisitions. Output is processed tomographic image data; assists clinicians in diagnostic interpretation by improving signal clarity.

Clinical Evidence

No clinical data provided; relies on established scientific principles of Compton-scatter correction documented in peer-reviewed literature.

Technological Characteristics

Computational software module; implements Triple Energy Window (T.E.W.) algorithm for scatter correction. No physical hardware changes to host gamma camera. Standalone software application.

Indications for Use

Indicated for all traditional and accepted gamma camera applications, particularly tomographic studies. No specific patient population or contraindications defined.

Regulatory Classification

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.

Predicate Devices

Toshiba GCA-7200A (K931297/A)

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Submission Summary (Full Text)

{0} DEC 23 1996 K960948 510(k) Summary Submitted by: Javad Seyedzadeh, Director of Regulatory Affairs 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 Compton-scatter effects are well understood and documented in peer-reviewed scientific publications.