AccessGUDID - DEVICE: DynaCAD (00858012005786)

GUDID

Device Identifier (DI) Information

Brand Name: DynaCAD
Version or Model: 3.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D4D0185
Company Name: Icad, Inc.

Primary DI Number: 00858012005786
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108870254 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 93e66bb3-1cb1-4894-bf49-53f93aa74535
Public Version Date: October 18, 2023
Public Version Number: 5
DI Record Publish Date: November 18, 2016