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Infinitt RT PACS

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K193498

by Infinitt Healthcare Co., Ltd.

Identifiers

510(k) Number
K193498 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Infinitt RT PACS is a Radiology Picture Archiving and Communication System (PACS) designed for radiotherapy workflows, enabling centralized storage, retrieval, and integration of diagnostic, oncological, surgical, and radiotherapy imaging data. It facilitates seamless data management across departments to support coordinated diagnosis and treatment planning in radiation oncology.

The system is supplied as a software solution for clinical environments and is intended for single-use or multi-user deployment within radiology and radiotherapy departments. Authorized under FDA 510K and MDD, it adheres to DICOM standards for imaging data exchange and is classified under product code LLZ for radiology advisory review. No sterility or MRI safety classifications are specified.

Frequently asked questions

What clinical workflows does the Infinitt RT PACS support, and how does it integrate with existing systems?

The Infinitt RT PACS is specifically designed to streamline radiotherapy workflows by providing centralized storage and retrieval of imaging data, including diagnostic, oncological, surgical, and radiotherapy images. It integrates seamlessly with existing systems through adherence to DICOM standards, enabling smooth data exchange and coordination between radiology and radiotherapy departments. This facilitates unified diagnosis and treatment planning across teams.

Is the Infinitt RT PACS intended for single-user or multi-user environments, and how is it deployed?

The Infinitt RT PACS is supplied as a software solution and is intended for multi-user deployment within clinical environments like radiology and radiotherapy departments. It is not a physical device but rather an IT system that requires installation on hospital networks to support collaborative workflows across multiple users.

What regulatory pathways does the Infinitt RT PACS follow, and how does this affect its use in clinical settings?

The Infinitt RT PACS has been authorized through FDA 510K clearance and MDD (Medical Device Directive) compliance, confirming its safety and performance for intended clinical use. The product code LLZ indicates it falls under radiology advisory review, ensuring it meets regulatory standards for imaging systems. Clinicians can rely on its compliance with these pathways for trusted integration into radiotherapy workflows.

Does the Infinitt RT PACS require any special handling, such as sterility or MRI safety considerations?

Since the Infinitt RT PACS is a software-based system and not a physical medical device, it does not have sterility or MRI safety classifications. It operates on hospital networks and does not interact directly with patients or MRI environments, so no special handling beyond standard IT deployment and maintenance is required.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RT PACS | INFINITT - infinitteurope, INFINITT Healthcare, INFINITT PACS | INFINITT North America, Radiology PACS | INFINITT - infinitteurope

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Infinitt Healthcare Co., Ltd.

Sources (2)

  • FDA 510(k) K193498 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026