FDA Registration
Active
🇮🇳 India
DeepTek CXR Analyzer
Reg #: 3038187462
·
FEI: 3038187462
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DEEPTEK MEDICAL IMAGING PVT. LTD
- Registration Number
- 3038187462
- FEI Number
- 3038187462
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3rd floor, Ideas to impact, Pallod Farms 3, Baner, Pune
- City
- Pune Maharashtra
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K231001
Owner / Operator
- Firm Name
- DeepTek Medical Imaging Pvt. Ltd
- Operator Number
- 10093139
- Address
- 3rd floor, Ideas to impact, Pallod Farms 3, Baner, Pune
- City
- Pune
- State
- Maharashtra
- Postal Code
- 411045
- Country
- IN
- Correspondent
- Kallol Sen
US Agent
- Business Name
- DeepTek Inc
- Contact Name
- Dalip Bhuchar
- Address
- 20 Elan Ln
- City
- Lake Ronkonkoma
- State
- NY
- ZIP
- 11779
- Country
- US
- [email protected]
- Phone
- 516 6350858
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Medical Image | MYN | Class 2 | Radiology | No | 2025-04-04 |
Proprietary Names
DeepTek CXR Analyzer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device