intelliMammo® densityAI™

GUDID 00628678950030

Version 2.8.4

Densitas Incorporated

Radiology DICOM image processing application software
Primary Device ID00628678950030
NIH Device Record Key56801023-f991-4b85-8275-55117b1d978d
Commercial Distribution StatusIn Commercial Distribution
Brand NameintelliMammo® densityAI™
Version Model Number2.x.y
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
GS100628678950030 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-07
Device Publish Date2023-10-30

On-Brand Devices [intelliMammo® densityAI™]

00628678950030Version 2.8.4
00628678950047Vesion 2.8.6

Trademark Results [intelliMammo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTELLIMAMMO
INTELLIMAMMO
90295872 not registered Live/Pending
Densitas Inc.
2020-11-03

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