# K082581: C-Quest

- Pathway: 510(k) (Traditional)
- Applicant: Medx, Inc.
- Decided: Nov 14, 2008 after 70 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: 1 generation back to K011611 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011611: Cardiocam Model 9CSY0799, Danish Diagnostic Development A/S (2001) Summary page 3.

## Indications for use
The C-Quest system is a dual head system designed to acquire data for cardiac multi-slice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 - 170 keV such as Tc-99m or TI-201.

Source page: https://510kreport.com/device/K082581
Methodology: https://510kreport.com/methodology