# K980715: Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS)

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: May 6, 1998 after 71 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.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Adac Cequal®: named in the summary without a submission number
- (no number) Sopha Sophy NXT: named in the summary without a submission number

## Most influential descendants
- K072468: Modification to D-Spect Cardiac Scanner System (2007), 10 descendants of its own
- K110507: Cardiac Scanner and Processing System (2011), 9 descendants of its own
- K161740: D-SPECT Scanner, D-SPECT L Scanner (2016), 5 descendants of its own
- K180514: Veriton NM (2018), 4 descendants of its own
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own

## Indications for use
The AutoQUANT, Quantitative Perfusion SPECT (QPS), and Quantitative Gated SPECT (QGS) applications are intended to enable a fully automated review and quantification of Cardiac SPECT data.

Source page: https://510kreport.com/device/K980715
Methodology: https://510kreport.com/methodology
