# K911752: Icon Teleradiology System

- Pathway: 510(k) (Traditional)
- Applicant: Icon Medical Systems, Inc.
- Decided: Jul 31, 1991 after 104 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
No predicates in its family tree.
849 later devices descend from it; 1 cites it directly.
1 of 850 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962699: Radworks Medical Imaging Software (1996), 848 descendants of its own
- K982862: Radworks Medical Imaging Software with Quality Control Module (1998), 463 descendants of its own
- K981535: Focus Pilot Contouring Workstation (1999), 354 descendants of its own
- K052379: Mim 3.5 (Circa) (2005), 353 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own

Source page: https://510kreport.com/device/K911752
Methodology: https://510kreport.com/methodology