# K043441: Mirage, Release 5.5

- Pathway: 510(k) (Special)
- Applicant: Segami Corporation
- Decided: Jan 13, 2005 after 30 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
No predicates in its family tree.
98 later devices descend from it; 4 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061545: Scenium 1.1 (2006), 91 descendants of its own
- K121074: Scenium 2.0 (2012), 90 descendants of its own
- K123528: Scenium (2012), 79 descendants of its own
- K130884: Xeleris 3.1 Processing and Review Workstation (2013), 77 descendants of its own
- K153355: Xeleris 4.0 Processing and Review Workstation (2016), 60 descendants of its own

## Indications for use
The Mirage Release 5.5 system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

Source page: https://510kreport.com/device/K043441
Methodology: https://510kreport.com/methodology