Address:39141 Civic Center Drive, Suite 240,Fremont,CA,94538,US
Device Description : AQAPS, also known as AquariusAPS Server, is a stand-alone medical device softwar AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : No
Device Description : The AquariusAPS server is a stand-alone medical device software which performs v The AquariusAPS server is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : Yes
Device Description : Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Device Class : 1
Duns Number: 021677872
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An application software program designed to function as a portal to allow softwa An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.
Device Class : 1
Duns Number: 021677872
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Intuition (also referred to as Aquarius Intuition) is a medical device comprised Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse.Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : No
Device Description : Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstatio Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewe Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for mobile devices.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) i Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of Intuition EMV (aka iNtuitionEMV) with a focus on 3D rendering, additionally providing workflow and scene support.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, sto The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits and post-processes medical images from acquisition devices in DICOM and non-DICOM formats.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : Yes
Device Description : ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities.
Device Class : 2
Duns Number: 021677872
Premarket Exempt : No
Prescription Use : Yes