Identity
- Trade Name
- Merge Eye Care PACS FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Standalone software application FDA UDI
- Model / Reference
- 5.1.1 Patch 1 FDA UDI
- Description
- Standalone software application FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842000100553 FDA UDI
- 510(k) Number
- K110006 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Merge Eye Care PACS by Merge Healthcare Solutions Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merge Healthcare Solutions Inc.
Sources (1)
- FDA UDI cc0d5983-09b8-4177-ac8e-ec7893f67054 35 fields · synced May 30, 2026