# K003358: QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect)

- Pathway: 510(k) (Traditional)
- Applicant: Smv America
- Decided: Jan 19, 2001 after 85 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.
355 later devices descend from it; 1 cites it directly.
1 of 356 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011572: Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) (2001), 354 descendants of its own
- 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

Source page: https://510kreport.com/device/K003358
Methodology: https://510kreport.com/methodology
