# K080770: Imagenmd with Imagenq

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Technologies, LLC
- Decided: Apr 9, 2008 after 22 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
No predicates in its family tree.
23 later devices descend from it; 3 cite it directly.
0 of 24 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) Ecat Lso Pet/CT 16: named in the summary without a submission number
- (no number) EMORY Cardiac Toolbox: named in the summary without a submission number

## Most influential descendants
- K083327: Syngocirculation Dynamicpet, Version 1.0 (2009), 20 descendants of its own
- K101279: CORRIDOR4DM V2010 Model: V2010 (2010), 12 descendants of its own
- K113754: CFR Quant (2012), 9 descendants of its own
- K143664: HeartSee (2015), 6 descendants of its own
- K110494: Syngo MBF (2011), 6 descendants of its own

## Indications for use
The ImagenMDT M with ImagenQ TM system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.

Source page: https://510kreport.com/device/K080770
Methodology: https://510kreport.com/methodology