# K020300: Northwestern Gated Blood Pool Spect (Numugas)

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: Apr 23, 2002 after 84 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: 3 generations back to K954874 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992450: Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers, Emory University (1999) Summary page 1.

## Most influential descendants
- K042258: BP-Spect V1.O (2004), 0 descendants of its own

## Indications for use
The Northwestern Gated Blood Pool SPECT (NUMUGAS™) software program is indicated to use for the display of wall motion and quantification of left ventricular functional parameters from gated Tc-99m Blood Pool SPECT studies.

Source page: https://510kreport.com/device/K020300
Methodology: https://510kreport.com/methodology