FDA Registration
Active
🇺🇸 United States
Merge Healthcare Incorporated
Reg #: 2183926
·
FEI: 1000116130
·
Expires 2026
Products
4
Proprietary Names
14
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Merge Healthcare Incorporated
- Registration Number
- 2183926
- FEI Number
- 1000116130
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 900 Walnut Ridge Dr
- City
- Hartland
- State
- WI
- ZIP
- 53029
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022881
Owner / Operator
- Firm Name
- Merge Healthcare
- Operator Number
- 10024020
- Address
- 900 Walnut Ridge Drive
- City
- Hartland
- State
- WI
- Postal Code
- 53029
- Country
- US
- Correspondent
- Nadia Marchant
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2011-11-21 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2016-12-22 |
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2011-11-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-01-15 |
Proprietary Names
Merge OrthoCase
Merge Hemo
Merge Eye Care PACS
Merge Cardio
iConnect Access
Merge OrthoTemplates
Merge Universal Viewer
Merge Hemo Model RCSV2
Merge Unity
Merge PACS
Merge OrthoPACS
IBM iConnect Access
CADstream
RadSuite
Establishment Types
Manufacture Medical Device