Identity
- Trade Name
- RadiCS FDA UDI
- Generic Name
- Radiology workstation display quality assurance software FDA UDI
- Device Name
- Quality Control Software FDA UDI
- Model / Reference
- Ver.5.2.x FDA UDI
- Description
- Quality Control Software FDA UDI
Identifiers
- Catalog Number
- RadiCS FDA UDI
- Primary DI / UDI-DI
- 04995047067740 FDA UDI
- FDA Product Code
- LHO FDA UDI
- GMDN Term
- Radiology workstation display quality assurance software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology workstation display quality assurance software
RadiCS by Eizo Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology workstation display quality assurance software.
- QAWeb Enterprise — Barco, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eizo Corporation
Sources (1)
- FDA UDI 809bd041-1c17-43fd-b41e-a6f747661039 35 fields · synced Jun 8, 2026