# K183133: MRCP+ v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Perspectum Diagnostics, Ltd.
- Decided: Jan 9, 2019 after 57 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: 8 generations back to K954678 (1996). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131498: Iqqa-Liver Multimodality Software, Edda Technology, Inc. (2013) Summary page 4.

## Most influential descendants
- K233930: MRCP+ version 2 (MRCP+ v2) (2024), 0 descendants of its own

## Indications for use
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data. MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder. Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment. MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols. MRCP+v1 is suitable for all patients not contra-indicated for MRI.

Source page: https://510kreport.com/device/K183133
Methodology: https://510kreport.com/methodology