Question 1

What types of medical devices does Agfa Healthcare Corp. primarily manufacture?

Accepted Answer

Agfa Healthcare Corp. specializes in radiological Picture Archiving and Communication Systems (PACS) software. Their portfolio includes software solutions like IMPAX and its clinical applications, PACS workstation tools such as the IMPAX SE SIGMACOM client, computed radiography systems paired with NX2.X workstations, and specialized orthopedic software designed for IMPAX workstations. These products focus on digital imaging and data management in radiology workflows.

Question 2

Where is Agfa Healthcare Corp. based, and how does this affect their device regulations?

Accepted Answer

Agfa Healthcare Corp. is based in the United States, which means their devices fall under FDA jurisdiction. Since they develop radiological PACS software and related systems, these products are classified under the FDA’s Class II regulatory category, indicating a moderate level of risk that requires compliance with specific regulatory controls. Their devices are also listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries, reflecting their regulatory oversight.

Question 3

Which regulatory registries list Agfa Healthcare Corp.’s devices, and why are these important?

Accepted Answer

Agfa Healthcare Corp.’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, ensuring it meets safety and effectiveness standards. The UDI system provides a unique identifier for each device, improving tracking, traceability, and transparency in the healthcare supply chain, which is critical for patient safety and regulatory compliance.

Question 4

How are Agfa Healthcare Corp.’s devices classified by the FDA, and what does this classification imply?

Accepted Answer

Agfa Healthcare Corp.’s devices are classified under the FDA’s Class II category. This classification indicates that while the devices pose a moderate risk, they are not low-risk (Class I) or high-risk (Class III). As a result, they require special controls beyond general controls to ensure their safety and performance, such as performance standards, post-market surveillance, or labeling requirements. The classification ensures that these radiological PACS and related systems meet rigorous regulatory standards before entering the market.

Device	Model / Reference	Registries	Class	Status
Enterprise Imaging Desktops	8.1.1	FDA UDI	Class II	Unknown
Enterprise Imaging XERO Viewer	8.1.1	FDA UDI	Class II	Unknown
Impax	IMPAX 6.7	FDA UDI	Class II	Unknown
Impax	6	FDA UDI	Class II	Active
IMPAX Clinical Applications	4	FDA UDI	Class II	Active
Enterprise Imaging Desktops	8.1.2	FDA UDI	Class II	Unknown
Enterprise Imaging Xero Viewer	Enterprise Imaging Xero Viewer 8.1	FDA UDI	Class II	Unknown
Enterprise Imaging Desktops	Enterprise Imaging Desktops 8.1	FDA UDI	Class II	Unknown
Enterprise Imaging XERO Viewer	8.1.2	FDA UDI	Class II	Unknown
Orthogon	K073271	FDA 510(k)	Class II	Active
Impax Se Sigmacom Client (pacs Workstation)	K071297	FDA 510(k)	Class II	Active
Agfa Computed Radiography System With Nx2.x Workstations	K071162	FDA 510(k)	Class II	Active
Impax Ma3000 Diagnostic Pacs Workstation	K081976	FDA 510(k)	Class II	Active
Drystar Axys, Model Eyz4e	K072680	FDA 510(k)	Class II	Active
Registration And Fusion	K080013	FDA 510(k)	Class II	Active
Agfa Computed Radiography Systems With Nx2008 Workstations	K081963	FDA 510(k)	Class II	Active
Orthopedic Software For Impax Workstations	K071972	FDA 510(k)	Class II	Active

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