# K972886: Mirage

- Pathway: 510(k) (Traditional)
- Applicant: Segami Corp., Inc.
- Decided: Oct 1, 1997 after 57 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
Longest line of descent: 1 generation back to K914350 (1991). 2 ancestors in all.
413 later devices descend from it; 4 cite it directly.
1 of 416 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914350: Icon Computer System, Siemens Gammasonics, Inc. (1991) Summary page 2.
- K913641: Sophy NXT, Sopha Medical Systems, Inc. (1991) Summary page 2.

## Most influential descendants
- K041022: Neuroq - Pet DP (2004), 382 descendants of its own
- 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

## Indications for use
The Mirage system is indicated for the acquisition, formatting and storage of scintigraphy camera output data. 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/K972886
Methodology: https://510kreport.com/methodology
