DynaCAD

Basic Information

• Brand Name: DynaCAD
• Primary DI: 00858012005786
• Version / Model: 3.5
• Catalog Number: D4D0185
• Company Name: Icad, Inc.
• Labeler DUNS: 108870254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-18
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 93e66bb3-1cb1-4894-bf49-53f93aa74535

Device Description

The DynaCAD 3 software consists of the MR Analysis Server software and the viewer workstation software. The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD Advanced PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images. The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. DynaCAD 3 software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD 3 software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858012005786	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]