# K222895: DynamicIQ

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Nov 22, 2022 after 60 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: 16 generations back to K002715 (2000). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193178: Biograph Horizon, Siemens Medical Solution USA, Inc. (2020) Summary page 6.

## Indications for use
DynamicIQ enables visualization and quantification of PET tracer pharmacokinetics based on whole body dynamic PET images. PET tracer pharmacokinetics include the physiological parameters of tracer uptake rate (Ki), metabolic rate of the tracer and total blood distribution volume (Vd) that allow for analyzing and visualizing the tracer accumulation over time, providing additional information that may help in the evaluation of SUV measurements on PET static images. The output of DynamicIQ is intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring. The parametric images should always be considered in addition to the conventional static PET images, which are the primary source to assist with diagnosis.

Source page: https://510kreport.com/device/K222895
Methodology: https://510kreport.com/methodology