# K011572: Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)

- Pathway: 510(k) (Traditional)
- Applicant: Digirad Corp.
- Decided: Jun 15, 2001 after 25 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: 2 generations back to K885054 (1989). 4 ancestors in all.
354 later devices descend from it; 1 cites it directly.
1 of 359 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982855: Digirad 2020TC Spect Imaging System, Digirad Corp. (1998) Summary page 2.
- K003358: QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect), Smv America (2001)

## Most influential descendants
- K052379: Mim 3.5 (Circa) (2005), 353 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K062163: Mimviewer (2006), 166 descendants of its own

## Indications for use
The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.

Source page: https://510kreport.com/device/K011572
Methodology: https://510kreport.com/methodology