FDA Registration
Active
🇺🇸 United States
1.5T eCoil Imaging System Disposables Prostate
Reg #: 3015431711
·
FEI: 3015431711
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DXTX MEDICAL INC.
- Registration Number
- 3015431711
- FEI Number
- 3015431711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 639 Alpha Drive
- City
- Pittsburgh
- State
- PA
- ZIP
- 15238
- Country
- US
Regulatory Submissions
- 510(k) Number
- K901888
Owner / Operator
- Firm Name
- DxTx Medical Inc.
- Operator Number
- 10061391
- Address
- 639 Alpha Drive
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15238
- Country
- US
- Correspondent
- Paul Lawson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2019-10-14 |
Proprietary Names
1.5T eCoil Imaging System Disposables Prostate
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device