DM-Density

GUDID 10627843712753

Densitas Incorporated

Radiology DICOM image processing application software
Primary Device ID10627843712753
NIH Device Record Key1420fb2e-a89b-4cca-82bb-e42b9f185ed6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDM-Density
Version Model Number2.1.0b
Company DUNS204371579
Company NameDensitas Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110627843712753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2018-03-16

Devices Manufactured by Densitas Incorporated

00628678950047 - intelliMammo® densityAI™2024-09-16 Vesion 2.8.6
00628678950030 - intelliMammo® densityAI™2023-11-07 Version 2.8.4
00628678950023 - intelliMammo™ densityAI™2022-12-07 Version 2.8.0
00628678950016 - densitas® densityAI™2022-05-11 Version 2.7.0
10627843712777 - densitas® densityai™2020-09-02 densitas® densityai™ 2.6.2
10627843712753 - DM-Density2019-10-07
10627843712753 - DM-Density2019-10-07
10627843712760 - densitasdensity2019-10-07 densitasdensity 2.4.1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.