# K914350: Icon Computer System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Gammasonics, Inc.
- Decided: Nov 22, 1991 after 56 days
- Product code: JWM (System, Tomographic, Nuclear)
- Device class: 2
- Regulation: 21 CFR 892.1310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
419 later devices descend from it; 3 cite it directly.
1 of 420 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972886: Mirage (1997), 413 descendants of its own
- 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

## Recalls of this device
- Feb 10, 2003 · Not classified · Z-0727-03: ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.

Source page: https://510kreport.com/device/K914350
Methodology: https://510kreport.com/methodology