# K983514: Positron Option, Model Nsco-050A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Dec 23, 1998 after 77 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Siemens E.CAM Coincidence Mode Option: named in the summary without a submission number

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). A. Planar Imaging B. Whole Body imaging C. Tomographic Imaging (SPECT) for non Positron Emitter D. Positron Imaging by Coincidence E. Positron Imaging without Coincidence F. Positron Whole Body Imaging by Coincidence

Source page: https://510kreport.com/device/K983514
Methodology: https://510kreport.com/methodology