Question 1

What types of medical devices does INFINITT Healthcare Co., Ltd. primarily manufacture?

Accepted Answer

INFINITT Healthcare Co., Ltd. specializes in radiological Picture Archiving and Communication Systems (PACS) software. Their portfolio includes solutions for radiology, cardiology, and dental imaging, such as systems for 3D reconstruction (e.g., Xelis 3D), automated colon analysis (RapidiaColon System), and mobile radiology workflows (INFINITT RT Mobile). These tools are designed to manage, process, and integrate imaging data across different medical specialties.

Question 2

Where is INFINITT Healthcare Co., Ltd. based, and how does this affect its regulatory compliance?

Accepted Answer

INFINITT Healthcare Co., Ltd. has a presence in the United States, which means their devices must comply with FDA regulations. Their products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their alignment with FDA requirements. Compliance depends on the device classification, with some falling under general software controls (e.g., Class I) and others under stricter imaging-specific regulations (e.g., Class II).

Question 3

Which regulatory registries list INFINITT Healthcare Co., Ltd.’s devices, and why is this important?

Accepted Answer

INFINITT Healthcare Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is important because it provides transparency on authorized devices, helps healthcare providers verify product legitimacy, and ensures traceability for regulatory and quality purposes. Listing in the UDI database also supports compliance tracking and post-market surveillance.

Question 4

How are INFINITT Healthcare Co., Ltd.’s devices classified under FDA regulations, and what does this mean?

Accepted Answer

INFINITT Healthcare Co., Ltd.’s devices are classified under FDA’s Class I and Class II categories. Class I generally includes low-risk devices with general controls, while Class II requires additional performance standards due to moderate risk. For example, imaging software like PACS systems may fall under Class II if they involve critical workflows or data processing that impact patient care decisions, requiring stricter validation and compliance measures.

Device	Model / Reference	Registries	Class	Status
Infinitt Rt Pacs	INFINITT RT PACS	FDA UDI	Class II	Active
INFINITT Cardiology PACS	INFINITT Cardiology PACS	FDA UDI	Class II	Active
RapidiaColon System	RapidiaColon System	FDA UDI	Class II	Active
INFINITT ULite	INFINITT ULite	EUDAMEDFDA UDI	Class II	Active
Xelis 3D	Xelis 3D	FDA UDI	Class II	Active
Xelis Dental	Xelis Dental	FDA UDI	Class II	Active
Xelis Fusion	Xelis Fusion	FDA UDI	Class II	Active
Reformat Gateway	Reformat Gateway	FDA UDI	Class II	Active
STARPACS Dental	STARPACS Dental	FDA UDI	Class II	Active
INFINITT RT Mobile	INFINITT RT Mobile	FDA UDI	Class I	Active
Xelis Cardiac	Xelis Cardiac	FDA UDI	Class II	Active
Xelis	Xelis	FDA UDI	Class II	Active
Infinitt Pacs	INFINITT PACS 7.0	FDA UDI	Class II	Active
STARPACS Orthopedics System	STARPACS Orthopedics System	EUDAMEDFDA UDI	Class II	Active

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