Question 1

What types of medical devices does Barco, Inc. manufacture?

Accepted Answer

Barco, Inc. specializes in medical imaging and audiovisual solutions. Their portfolio includes radiology picture archiving and communication system (PACS) workstations, operating room audiovisual data management systems, and high-quality colour image display units. They also produce endoscopic video image processing units, digital pathology image display systems for in vitro diagnostics (IVD), and software designed for radiology workstation display quality assurance. These devices support diagnostic, surgical, and pathology workflows by enhancing image clarity, integration, and management.

Question 2

Where is Barco, Inc. based, and what regulatory databases list their devices?

Accepted Answer

Barco, Inc. is headquartered in the United States. Their devices are listed in two key regulatory databases: the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency and traceability for healthcare professionals, regulators, and patients, allowing them to verify and track specific devices authorized for use in their respective markets.

Question 3

How are Barco, Inc.’s medical devices classified under regulatory frameworks?

Accepted Answer

Barco, Inc.’s devices fall under Class I and Class II regulatory classifications. Class I typically includes low-risk devices like some display units or basic audiovisual systems, while Class II covers moderate-risk devices such as advanced imaging workstations or software that may impact diagnostic accuracy. The classification determines the regulatory scrutiny and requirements for authorization, ensuring appropriate oversight based on the device’s potential risk to patients.

Question 4

Are Barco’s devices used in specific medical specialties, and how do they integrate into workflows?

Accepted Answer

Barco’s devices are designed for critical specialties like radiology, surgery, and pathology. Their radiology PACS workstations and display quality assurance software streamline image storage, retrieval, and analysis for diagnostic accuracy. Operating room audiovisual systems integrate with surgical tools to enhance visualization and data management, while endoscopic and digital pathology displays support precise examination of tissue samples. These solutions are built to reduce workflow disruptions and improve collaboration among healthcare teams.

Device	Model / Reference	Registries	Class	Status
Nio Color 2MP LED	MDNC-2221	FDA UDI	Class II	Active
Demetra	Analytics Toolkit	FDA UDI	Class II	Unknown
Clinical review 2MP	MDRC-2221 HLX	FDA UDI	Class I	Unknown
Nio Color 3MP LED	MDNC-3321	FDA UDI	Class II	Unknown
Coronis 5MP Mammo	MDMG-5121	FDA UDI	Class II	Unknown
Coronis 3MP LED	MDCG-3221	FDA UDI	Class II	Active
Barco	MDSC-8255	FDA UDI	Class I	Active
Nio 5MP LED	MDNG-5221	FDA UDI	Class II	Unknown
Barco Mammo Tomosynthesis	MDMG-5221	FDA UDI	Class II	Unknown
Nexxis	NEXXIS SYSTEM ST KIT 2	FDA UDI	Class II	Unknown
Nio Color 3MP	MDNC-3421	FDA UDI	Class II	Active
Barco	MDSC-8255	FDA UDI	Class I	Active
Nexxis	Nexxis OR	FDA UDI	Class II	Active
Barco	MDRC-2222	FDA UDI	Class I	Active
Stryker	0240-099-255	FDA UDI	Class I	Active
Nexxis	MNA-110	FDA UDI	Class II	Active
Nio 3MP LED	MDNG-3220	FDA UDI	Class II	Active
Nexxis	MNT-120	FDA UDI	Class II	Unknown
Barco	MDSC-8532	FDA UDI	Class I	Active
Nexxis	MNA-120	FDA UDI	Class II	Unknown
Nio Color 2MP	MDNC-2123	FDA UDI	Class II	Unknown
Barco	MDSC-8358	FDA UDI	Class I	Unknown
Clinical review 2MP	MDRC-2122 BL	FDA UDI	Class I	Unknown
Eonis 22"	MDRC-2422	FDA UDI	Class I	Active
Nexxis	MNA-110	FDA UDI	Class II	Unknown
Stryker	0240-031-050	FDA UDI	Class I	Active
Coronis 5MP Mammo	MDMG-5121	FDA UDI	Class II	Unknown
Nio 3MP LED	MDNG-3220	FDA UDI	Class II	Active
Coronis 5MP	MDCG-5221	FDA UDI	Class II	Unknown
Nio Color 3MP LED	MDNC-3321	FDA UDI	Class II	Unknown
Nexxis	MNA-120	FDA UDI	Class II	Unknown
Nexxis	MNA-110	FDA UDI	Class II	Unknown
Barco	MDSC-8255	FDA UDI	Class I	Active
Nexxis	MNA-120	FDA UDI	Class II	Active
Clinical review 1MP	MDRC-1119	FDA UDI	Class I	Unknown
Nio 3MP LED	MDNG-3220	FDA UDI	Class II	Active
Nexxis	MNA-110	FDA UDI	Class II	Unknown
Barco	MDRC-1219	FDA UDI	Class I	Unknown
Coronis Fusion 4MP	MDCC-4130	FDA UDI	Class II	Unknown
Nexxis OR	NEXXIS system	FDA UDI	Class II	Active
Nexxis	MNA-110	FDA UDI	Class II	Unknown
Barco	MDSC-8527	FDA UDI	Class I	Active
Barco Mammo Tomosynthesis	MDMG-5221	FDA UDI	Class II	Unknown
Nexxis OR	NEXXIS system	FDA UDI	Class II	Active
Nexxis	MNA-110	FDA UDI	Class II	Unknown
Nexxis OR	Nexxis	FDA UDI	Class II	Active
Barco	Acquiris 19	FDA UDI	Class I	Unknown
Nexxis OR	Nexxis	FDA UDI	Class II	Active
Nexxis	MNT-120	FDA UDI	Class II	Unknown
Nio 3MP	E-3620	FDA UDI	Class II	Unknown

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