Identity
- Trade Name
- Coronis 3MP LED FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Model / Reference
- MDCG-3221 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05415334000162 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiology picture archiving and communication system workstation
Coronis 3MP LED by Barco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology picture archiving and communication system workstation.
- WorkstationOne™ — Three Palm Software · Class II
- OTOPLAN — CAScination AG · Class II
- RamSoft — Ramsoft Inc · Class II
- Aline Ablation Intelligence — Mirada Medical, Ltd. · Class II
- Sectra Orthopedic Package — Sectra AB · Class II
- CHILI PACS — CHILI GmbH · Class II
- RamSoft — Ramsoft Inc · Class II
- RadSuite — MERGE HEALTHCARE SOLUTIONS INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Barco, Inc.
Sources (1)
- FDA UDI eebf7690-62a9-49f7-af89-36bdfb1f2283 33 fields · synced May 31, 2026