# K050736: Imorgon Ultrasound Pacs Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Sea Ridge Software, Inc.
- Decided: May 5, 2005 after 45 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: 4 generations back to K950279 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023772: Kinetdx Picture Archiving and Communications System, Acuson Corp. (2002) Summary page 1.

## Indications for use
imorgon Ultrasound PACS Solutions is a medical image and information management system that is intended to transmit, store, retrieve, print and process DICOM digital medical images and associated medical information from various ultrasound imaging systems. It may also be used for general radiogical viewing from other modalities such as MRI, CT or nuclear medicine. imorgon Ultrasound PACS Solutions is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians and medical technologists. imorgon is also indicated for soft copy diagnostic interpretation of medical images and video by physicians trained in such practice. 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/K050736
Methodology: https://510kreport.com/methodology