FDA Registration
Active
🇺🇸 United States
XR90 System, LOGIQ
Reg #: 3016110967
·
FEI: 3016110967
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDIVIEW XR
- Registration Number
- 3016110967
- FEI Number
- 3016110967
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10000 Cedar Ave, STE GCIC2-153
- City
- Cleveland
- State
- OH
- ZIP
- 44106
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223125
Owner / Operator
- Firm Name
- MediView XR
- Operator Number
- 10081343
- Address
- 10000 Cedar Ave, STE GCIC2-153
- City
- Cleveland
- State
- OH
- Postal Code
- 44106
- Country
- US
- Correspondent
- Adam Cargill
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-10-19 |
Proprietary Names
XR90 System, LOGIQ
XR90 System, Vivid
Registration Marker Kit, Sterile, Single
EM Probe Bracket Kit, C1-5, Single
EM Probe Bracket Kit, C1-6, Single
XR90 System, LOGIQ, Upgrade Kit
Triangle Template Kit
XR90 System, LOGIQ, Single Headset
Establishment Types
Manufacture Medical Device