FDA Registration
Active
🇮🇳 India
QURE.AI TECHNOLOGIES PRIVATE LIMITED
Reg #: 3017840913
·
FEI: 3017840913
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- QURE.AI TECHNOLOGIES PRIVATE LIMITED
- Registration Number
- 3017840913
- FEI Number
- 3017840913
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6th Floor, Wing E, Times Square, Andheri-Kurla Road, Marol, Andheri (East),
- City
- Mumbai Maharashtra
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K200921
Owner / Operator
- Firm Name
- QURE.AI TECHNOLOGIES PRIVATE LIMITED
- Operator Number
- 10079068
- Address
- 6th Floor, Wing E, Times Square, Andheri-Kurla Road, Marol, Andheri (East),
- City
- Mumbai
- State
- Maharashtra
- Postal Code
- 400059
- Country
- IN
- Correspondent
- Bunty Kundnani
US Agent
- Business Name
- Biologics Consulting
- Contact Name
- MARGARET VERNON
- Address
- 100 Daingerfield Rd Ste 101
- City
- Alexandria
- State
- VA
- ZIP
- 22314
- Country
- US
- [email protected]
- Phone
- 703 7395695
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer-Assisted Triage And Notification Software | QAS | Class 2 | Radiology | No | 2020-11-17 |
| Analyzer, Medical Image | MYN | Class 2 | Radiology | No | 2024-05-30 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-11-27 |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | Class 2 | Radiology | No | 2023-10-09 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2023-06-28 |
Proprietary Names
qER
qXR-LN
qCT LN Quant
qXR-BT
qXR-PTX-PE
Qure App
Qure App v2
qXR-CTR
qER-Quant
Establishment Types
Manufacture Medical Device