# K124048: Imageqube

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Imaging Informatics, LLC
- Decided: Jan 29, 2013 after 29 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: 7 generations back to K954678 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051037: Imageqube Pacs, Intuitive Imaging Informatics, LLC (2005) Summary page 2.
- K082144: Amicas Pacs, Version 6.0, Amicas, Inc. (2008) Summary page 1.
- K080333: Imagegrid, Candelis, Inc. (2008) Summary page 1.
- K100881: Synapse Obliquus Mip/MPR/Fusion, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 1.

## Indications for use
ImageQube is intended for use by a physician or other medical professionals in the display and interpretation of medical images and demographic detail from all institutional imaging modalities, including, but not limited to, CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlays and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The ImageQube is designed for display, interpretation, storage and distribution of all modalities. Only pre-processed DICOM For Presentation images can be interpreted for primary diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be viewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor meeting all the technical specifications required by the FDA for the Performance of Screening and Diagnostic Mammography. Images that are printed to film must be done using an FDA-approved printer for the diagnosis of digital mammography images. Efficient mammography screening makes toolbars and thumbnails available on each monitor, while also handling DICOM overlay display. Acquired medical images may be displayed and manipulated further utilizing Multi-Planar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MWP), Slab and 3-D display, sent to and retrieved by radiologists in-house at facilities or at remote sites, stored, archived or printed. The ImageQube can operate as an independent device, or can also be interfaced with Rational Imaging PACS systems. Annotated print pages, transcribed reports and Key Image Summaries can also be accessed.

Source page: https://510kreport.com/device/K124048
Methodology: https://510kreport.com/methodology