# K233930: MRCP+ version 2 (MRCP+ v2)

- Pathway: 510(k) (Traditional)
- Applicant: Perspectum
- Decided: Mar 13, 2024 after 90 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: 9 generations back to K954678 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183133: MRCP+ v1.0, Perspectum Diagnostics, Ltd. (2019) Summary page 4.

## Indications for use
MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder. MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of the biliary system. These metrics support physicians in the visualization, evaluation and reporting of hepatobiliary structures. MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acquired on supported MR scanners using supported MRCP acquisition protocols.

Source page: https://510kreport.com/device/K233930
Methodology: https://510kreport.com/methodology