densitas® densityAI™

GUDID 00628678950016

Version 2.7.0

Densitas Incorporated

Radiology DICOM image processing application software
Primary Device ID00628678950016
NIH Device Record Keya7aa6e42-3bd0-494c-85b5-13ff7844eccd
Commercial Distribution StatusIn Commercial Distribution
Brand Namedensitas® 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
GS100628678950016 [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 Date2022-05-11
Device Publish Date2022-05-03

On-Brand Devices [densitas® densityAI™]

10627843712777densitas® densityai™ 2.6.2
00628678950016Version 2.7.0

Trademark Results [densitas]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DENSITAS
DENSITAS
87979037 not registered Live/Pending
Densitas, Inc.
2017-05-12
DENSITAS
DENSITAS
87447865 not registered Live/Pending
Densitas, Inc.
2017-05-12
DENSITAS
DENSITAS
86379034 not registered Dead/Abandoned
Densitas Inc.
2014-08-27

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