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CAAS MRV

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162112

by Pie Medical Imaging BV

Identifiers

510(k) Number
K162112 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CAAS MRV is quantitative analysis software designed for cardiovascular magnetic resonance imaging. It enables measurement and evaluation of heart function and peripheral arterial flow using 2D, M‑mode, Doppler, 3D phase‑contrast and 4D flow datasets.

The software is marketed by Pie Medical Imaging BV and has received FDA 510(k) traditional clearance (decision date 2016‑09‑21, decision code SESE, K number K162112, product code LLZ). It is supplied as a software package for use with MR scanners and is regulated under the FDA 510(k) pathway.

Frequently asked questions

What is the CAAS MRV software designed for?

CAAS MRV is quantitative analysis software designed for cardiovascular magnetic resonance imaging, enabling measurement and evaluation of heart function and peripheral arterial flow using various imaging datasets.

How is the CAAS MRV software supplied?

The software is supplied as a software package specifically designed for use with MR scanners to perform cardiovascular analysis.

What types of imaging datasets can be analyzed with CAAS MRV?

CAAS MRV can analyze 2D, M-mode, Doppler, 3D phase-contrast, and 4D flow datasets for cardiovascular assessment.

What is the regulatory status of CAAS MRV?

CAAS MRV has received FDA 510(k) traditional clearance with decision date September 21, 2016, and is regulated under the FDA 510(k) pathway.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pie Medical Imaging - Solutions in cardiovascular analysis, Caas MR Solutions - Pie Medical Imaging, MRV | MR Flow - Pie Medical Imaging - PDF Catalogs | Technical ..., Pie Caas MRV - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pie Medical Imaging BV

Sources (1)

  • FDA 510(k) K162112 24 fields · synced Sep 19, 2026