FDA Registration Active 🇦🇺 Australia

Annalise Triage

Reg #: 3023702863 · FEI: 3023702863 · Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1

Registration Details

Registration Name
ANNALISE-AI
Registration Number
3023702863
FEI Number
3023702863
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Level P, 24 Campbell Street
City
Sydney New South Wales
Country
AU

Regulatory Submissions

510(k) Number
K231094

Owner / Operator

Firm Name
Annalise-AI
Operator Number
10085806
Address
Level P, 24 Campbell St
City
Sydney
State
New South Wales
Postal Code
2000
Country
AU

US Agent

Business Name
Qserve Group US Inc.
Contact Name
Mindy McCann
Address
350 S Main Street, Suite 309
City
Doylestown
State
PA
ZIP
18901
Country
US
Phone
424 2718169

Products

Device Name Product Code
Radiological Computer-Assisted Triage And Notification Software QAS

Proprietary Names

Annalise Triage Annalise Triage OHCP Annalise Critical Care AI Annalise - OH Annalise Critical Care AI - OH Annalise Triage CTB Annalise - Obstructive Hydrocephalus Annalise Enterprise CTB Triage Trauma - OH Annalise Critical Care AI - Obstructive Hydrocephalus Annalise Triage OH

Establishment Types

Manufacture Medical Device