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Coronis Fusion 4MP

FDA UDI

Class II (US FDA UDI)

by Barco, Inc.

Identity

Trade Name
Coronis Fusion 4MP FDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Device Name
MDCC-4430 FDA UDI
Model / Reference
MDCC-4430 FDA UDI
Description
MDCC-4430 FDA UDI

Identifiers

Catalog Number
K9301626B2X FDA UDI
Primary DI / UDI-DI
05415334049895 FDA UDI
FDA Product Code
PGY 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 Fusion 4MP 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Barco, Inc.

Sources (1)

  • FDA UDI 8820ee3e-1a25-45e8-813b-2c3a9143f962 35 fields · synced Jun 8, 2026