# K060486: Cyclone, Model Maicam 180

- Pathway: 510(k) (Traditional)
- Applicant: Spectrica
- Decided: Mar 23, 2006 after 27 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 K001888 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031825: C.CAM, Danish Diagnostic Development A/S (2003) Summary page 1.

## Indications for use
The Cyclone is an emission computed tomography system intended to detect the location and distribution of gamma ray emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The data can then be transmitted to, or retrieved by, existing commercially available image processing software packages and accompanying computer equipment. The Cyclone intended use is for cardiac applications. The Cyclone supports radionuclides within the energy of 50-200keV.

Source page: https://510kreport.com/device/K060486
Methodology: https://510kreport.com/methodology