# K903315: ICON

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Gammasonics, Inc.
- Decided: Jan 9, 1991 after 169 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.
112 later devices descend from it; 3 cite it directly.
6 of 113 devices in its family (counting itself) have 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
- K992731: E.Cam Computer (1999), 111 descendants of its own
- K023190: E.Cam Computer / E.Soft Workstation (2002), 104 descendants of its own
- K041166: Siemens Enhanced Imaging System (2004), 87 descendants of its own
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own
- K072567: Symbia-E, Model 10275879 (2007), 85 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/K903315
Methodology: https://510kreport.com/methodology