# K960948: Scatter Correction Volume Software Model NSSC-020A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba Medical Systems
- Decided: Dec 23, 1996 after 290 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931297 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931297: GCA-7200A, Toshiba America Medical Systems, In.C (1993) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K960948
Methodology: https://510kreport.com/methodology