# K051037: Imageqube Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Imaging Informatics, LLC
- Decided: Jun 28, 2005 after 64 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 K954678 (1996). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022970: Amicas Light Beam Workstation, Model 1.0, Amicas, Inc. (2002) Summary page 1.

## Most influential descendants
- K124048: Imageqube (2013), 0 descendants of its own
- K063037: Centarisone Ris/Pacs (2006), 0 descendants of its own

## Indications for use
ImageQube is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The ImageQube Web system is designed for acquisition, storage, and distribution of all modalities. Device is also designed for primary interpretation of all modalities except mammography. Device is not to be used for primary imaging diagnosis in mammography and will be conspicuously labeled as such during display of mammography images. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Rational Imaging PACS Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.

Source page: https://510kreport.com/device/K051037
Methodology: https://510kreport.com/methodology