FDA Registration
Active
🇺🇸 United States
MEDIVIEW XR
Reg #: 3016110967
·
FEI: 3016110967
·
Expires 2026
Products
3
Proprietary Names
12
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MEDIVIEW XR
- Registration Number
- 3016110967
- FEI Number
- 3016110967
- Status
- Active
- Expiry Year
- 2026
- 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
- Crew J Weunski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-10-19 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2025-01-02 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2021-04-06 |
Proprietary Names
XR90 System, Vivid
EM Probe Bracket Kit, C1-5, Single
Registration Marker Kit, Sterile, Single
EM Probe Bracket Kit, C1-6, Single
XR90 System, LOGIQ, Upgrade Kit
Triangle Template Kit
XR90 System, LOGIQ, Single Headset
XR90 System, LOGIQ
Kit, Aurora FG Mounting Brackets, LT
Kit, Aurora FG Mounting Brackets, RT
MediScout system
OmnifyXR
Establishment Types
Manufacture Medical Device