# K040326: Autoquant Plus

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Feb 25, 2004 after 15 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 K003264 (2000). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980715: Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS), Adac Laboratories (1998) Summary page 1.
- K022428: Quantitative Blood Pool Spect (QBS), Adac Laboratories (2002) Summary page 1.

## Most influential descendants
- 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
AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoQUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided 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/K040326
Methodology: https://510kreport.com/methodology