# K063267: Isite Pacs, V 4. X

- Pathway: 510(k) (Traditional)
- Applicant: Stentor Inc., A Philips Medical Systems Co.
- Decided: Nov 9, 2006 after 10 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913770 (1991). 12 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1.
- K060055: Kodak Pacs, Eastman Kodak Company (2006) Summary page 1.
- K042292: Isite Pacs, Stentor, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K250181: AV Viewer (2025), 1 descendant of its own
- K261465: Indira Cloud Viewer (2026), 0 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
- Dec 29, 2008 · Not classified · Z-0948-2009: Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.
- 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
- Jan 29, 2008 · Not classified · Z-1444-2008: 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

## 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 a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. 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/K063267
Methodology: https://510kreport.com/methodology