FDA Registration Active 🇮🇳 India

Annalise Critical Care AI - Vasogenic Edema

Reg #: 3034396442 · FEI: 3034396442 · Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Annalise-AI India Pte Ltd
Registration Number
3034396442
FEI Number
3034396442
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Aneja Towers, 4th Floor Block A, Plot 4 & 5 Developed Plot Estate, OMR Perungudi
City
Chennai Tamil Nadu
Country
IN

Regulatory Submissions

510(k) Number
K231767

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 St Ste 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 Critical Care AI - Vasogenic Edema Annalise Critical Care AI Annalise Triage - Vasogenic Edema Annalise - Vasogenic Edema Annalise Triage CTB Annalise Triage

Establishment Types

Manufacture Medical Device