# K052618: Imagecast Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Idx Systems Corp.
- Decided: Nov 17, 2005 after 55 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920319 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042292: Isite Pacs, Stentor, Inc. (2004) Summary page 1.

## Recalls of this device
- Feb 18, 2013 · Class II · Z-2300-2016: A software defect was discovered that causes images to be out of context with clinical information.
- Mar 4, 2011 · Class II · Z-0773-2014: In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tag

## Indications for use
ImagecastTM 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 devices and 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 the FDA.

Source page: https://510kreport.com/device/K052618
Methodology: https://510kreport.com/methodology