# K041022: Neuroq - Pet DP

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: Jun 17, 2004 after 58 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 K914350 (1991). 4 ancestors in all.
382 later devices descend from it; 7 cite it directly.
1 of 387 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972886: Mirage, Segami Corp., Inc. (1997) Summary page 1.
- K010726: Modification to Mirage, Segami Corp., Inc. (2001) Summary page 1.

## Most influential descendants
- K042863: Scenium (2004), 380 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
- K062163: Mimviewer (2006), 166 descendants of its own

## Indications for use
NeuroQTM - PET DP Program is indicated to: 1) assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and 2) assist with comparisons of the activity in brain regions in of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.

Source page: https://510kreport.com/device/K041022
Methodology: https://510kreport.com/methodology