# K052963: Mediq Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Clario Medical Imaging, Inc.
- Decided: Dec 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: 7 generations back to K913770 (1991). 41 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993802: Sharpview Image Enhancement System, Context Vision AB (2000). Our reading of the summary gave K993082, FDA’s number for Exactech Acumatch Integrated Hip System a-Series Porous… (Exactech, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SharpView”.
- K043333: VITREA2, Version 3.7 Medical Image Processing System, Vital Images, Inc. (2004) Summary page 1.
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 2.
- K043350: Mistar, Model V3.2, Apollo Medical Imaging Technology Pty., Ltd. (2004) Summary page 2.
- K030982: Syngo Colonography Software Package, Siemens Medical Solutions USA, Inc. (2003) Summary page 2.
- K973010: Realtime 3D Diagnostic Workstation, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K971717: Fly Through, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.

## Most influential descendants
- K080196: Z3D Contrast Acuity (2008), 10 descendants of its own
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own
- K210670: BU-CAD (2021), 3 descendants of its own

## Indications for use
MedIQ is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input. The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. MedLQ also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET and Nuclear Medicine images. The software analysis tools may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections. The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization, and a z-axis kinematic motion feature. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of MedIQ analysis. The MedlQ software is not intended for use for primary interpretation of digital mammography images.

Source page: https://510kreport.com/device/K052963
Methodology: https://510kreport.com/methodology