DynaCAD D4D0185

GUDID 00858012005786

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.

Icad, Inc.

Radiology PACS software

• Primary Device ID: 00858012005786
• NIH Device Record Key: 93e66bb3-1cb1-4894-bf49-53f93aa74535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCAD
• Version Model Number: 3.5
• Catalog Number: D4D0185
• Company DUNS: 108870254
• Company Name: Icad, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com
• Phone: 866-821-2239
• Email: support@icadmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005786 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-11-18

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• 00850008977299 - PowerLook PRO+ 4GPU Tower Platform, OUS: 2024-06-18
• 00850008977305 - PowerLook 10.1.1: 2024-06-18
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