# K042292: Isite Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Stentor, Inc.
- Decided: Sep 8, 2004 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920319 (1992). 4 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023557: Centricity Pacs Plus, GE Medical Systems (2002) Summary page 1.
- K030781: Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak Directview CX/DX, Kodak Directvib, Eastman Kodak Company (2003) Summary page 1.

## Most influential descendants
- K063267: Isite Pacs, V 4. X (2006), 8 descendants of its own
- K111804: Intellispace Pacs 4.X (2011), 5 descendants of its own
- K160315: I4 (Integrated Intelligent Imaging Informatics) system (2016), 3 descendants of its own
- K173588: Illumeo System (2018), 2 descendants of its own
- K051809: Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System (2005), 2 descendants of its own

## Recalls of this device
- Feb 23, 2011 · Not classified · Z-1881-2011: A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of th
- Aug 29, 2008 · Not classified · Z-0118-2009: Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presen
- Jul 3, 2008 · Not classified · Z-2346-2008: Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
- Jan 29, 2008 · Not classified · Z-1443-2008: When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the
- Jan 4, 2008 · Not classified · Z-1141-2008: Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is 
- Feb 14, 2007 · Not classified · Z-0616-2007: A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.
- Dec 20, 2005 · Not classified · Z-0399-06: When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagn

## Indications for use
iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging device or modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K042292
Methodology: https://510kreport.com/methodology