# K022428: Quantitative Blood Pool Spect (QBS)

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Aug 6, 2002 after 12 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K003264 (2000). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003264: QPS/BPGS/Moco Processing Applications for Entegra Workstation, Ge Medical Systems F.I. Haifa (2000) Summary page 2.

## Most influential descendants
- K040326: Autoquant Plus (2004), 3 descendants of its own
- K060020: Autoquant Plus (2006), 1 descendant of its own
- K213731: EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows (2022), 0 descendants of its own
- K100714: CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01 (2011), 0 descendants of its own

## Indications for use
Quantitative Blood Pool SPECT (QBS) is a standalone software application for the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

Source page: https://510kreport.com/device/K022428
Methodology: https://510kreport.com/methodology