Densitas Inc

FDA Filings

This page includes the latest FDA filings for Densitas Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014343888
• FEI Number: 3014343888
• Name: Densitas Inc.
• Owner & Operator: Densitas Inc
• Contact Address: #66, 1344 Summer Street ; Halifax CA-NS Nova Scotia B3H 0A8 CA
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: #66, 1344 Summer Street ; Halifax Nova Scotia, B3H 0A8 CA
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00628678950047 Densitas Incorporated	intelliMammo® densityAI™	2024-09-16
GUDID 00628678950030 Densitas Incorporated	intelliMammo® densityAI™	2023-11-07
GUDID 00628678950023 Densitas Incorporated	intelliMammo™ densityAI™	2022-12-07
GUDID 00628678950016 Densitas Incorporated	densitas® densityAI™	2022-05-11
GUDID 10627843712777 Densitas Incorporated	densitas® densityai™	2020-09-02
PMN K192973 Densitas, Inc.	Densitas Densityai	2020-02-19
GUDID 10627843712760 Densitas Incorporated	densitasdensity	2019-10-07
GUDID 10627843712753 Densitas Incorporated	DM-Density	2019-10-07
LHO Densitas Inc. [Densitas Inc]	densitas qualityai (densitasimagecheck; densitasIRT; densitasPOC)	2018-10-30
LHO Densitas Inc. [Densitas Inc]	Pressure Software	2018-10-30
LHO Densitas Inc. [Densitas Inc]	Dose Software	2018-10-30
PMN K170540 | LLZ Densitas Inc. [Densitas Inc]	densitas densityai	2018-03-12
PMN K170540 Densitas, Inc.	DM-Density	2018-02-23