# K123302: IB Clinic

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Biometrics, LLC
- Decided: Jan 11, 2013 after 80 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: 11 generations back to K911667 (1991). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080762: IB Neuro, Version 1.0, Imaging Biometrics, LLC (2008) Summary page 2.
- K090546: Modification to Nordicice Software, Nordicimaginglab AS (2009) Summary page 2.

## Most influential descendants
- K211356: GIQuant (2021), 0 descendants of its own

## Indications for use
IS Clinic v1 -0 (Clinic) is a post-processing software toolkit designed to be integrated into existing medical image visualization applications running on standard computer hardware. Clinic accepts relevant DICOM image sets, such as dynamic perfusion and diffusion image sets. Clinic generates various perfusion- and diffusion-related parameters, standardized image sets, and image intensity differences. The results are saved to a DICOM image file and may be further visualized an an imaging workstation- Clinic is designed to aid trained physicians in advanced image assessment, treatment consideration, and monitoring of therapeutic response. The information provided by Clinic should not be used in isolation when making patient management decisions. Dynamic Perfusion Analysis - Generates parametric perfusion maps used for visualization of temporal variations in dynamic datasets, showing changes in image intensity over time- These maps may aid in the assessment of the extent and type of perfusion, blood volume and vascular permeability changes- Dynamic Diffusion Analysis - Generates apparent diffusion coefficient maps used for the visualization of apparent water movement in soft tissue throughout the body on both voxel-by-voxel and sub-voxel bases. These images may aid in the assessment of the extent of diffusion in tisue- Image Comparison - Generates co-registered image sets- Generates standardized image sets calibrated to an arbitrary scale to facilitate comparisons between independent image sets- Generates voxel-by-voxel maps of the image intensity differences between image sets acquired at different times- Facilitates selection and DICOM export of user-selected regions of interest (ROls)-These processes may enable easier identification of image intensity differences between images and easier selection and processing of ROls-

Source page: https://510kreport.com/device/K123302
Methodology: https://510kreport.com/methodology