Primary Device ID | 00628678950023 |
NIH Device Record Key | 233a87cc-8e35-4efe-951f-44315d2ac58e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | intelliMammo™ densityAI™ |
Version Model Number | 2.x.y |
Company DUNS | 204371579 |
Company Name | Densitas Incorporated |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00628678950023 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-07 |
Device Publish Date | 2022-11-29 |
00628678950030 - intelliMammo® densityAI™ | 2023-11-07 Version 2.8.4 |
00628678950023 - intelliMammo™ densityAI™ | 2022-12-07Version 2.8.0 |
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-Density | 2019-10-07 |
10627843712760 - densitasdensity | 2019-10-07 densitasdensity 2.4.1 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() INTELLIMAMMO 90295872 not registered Live/Pending |
Densitas Inc. 2020-11-03 |