# K013630: Isite Radiology

- Pathway: 510(k) (Traditional)
- Applicant: Stentor, Inc.
- Decided: Dec 5, 2001 after 30 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 K942120 (1994). 2 ancestors in all.
123 later devices descend from it; 7 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955092: Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print Spooler, Analog & Digital Acquire, Cemax-Icon, Inc. (1996) Summary page 1.
- K942120: Advantage Windows Diagnostic X-Ray Workstation, GE Medical Systems (1994) Summary page 1.

## Most influential descendants
- K031311: Integradweb by Dynamic Imaging, Inc. (2003), 115 descendants of its own
- K042313: Integradweb MPR/Mip (2004), 114 descendants of its own
- K052358: Etiam Star Pacs Components (2005), 56 descendants of its own
- K062488: IQ-System Pacs System (2006), 55 descendants of its own
- K063470: Aycan Workstation Osirix (2007), 49 descendants of its own

## Indications for use
Stentors’ iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology images.

Source page: https://510kreport.com/device/K013630
Methodology: https://510kreport.com/methodology