INFINITT ULite
510(k) K163290
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163290 | Date24 Mar 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The INFINITT ULite is an HTML5-based universal medical image viewer designed for radiology applications. It provides zero-footprint access to image data, clinical reports, and advanced visualization tools without requiring local software installation. This device enables seamless viewing and interpretation of medical images across desktop and mobile platforms, supporting workflow efficiency in diagnostic settings. Its classification aligns with radiology-specific imaging solutions, facilitating remote and on-demand access to diagnostic information.
The INFINITT ULite is supplied as a software application accessible via web browsers or mobile devices, eliminating the need for dedicated hardware or installations. It is intended for single-use per session, though the underlying platform may support multiple sessions depending on system configuration. The device operates in non-sterile environments, such as radiology departments or clinical workstations, and does not require sterilization. Authorized under FDA 510(k) clearance (K163290) as substantially equivalent under the Radiology Advisory Committee, it adheres to regulatory standards for digital imaging solutions.
Other devices from Infinitt Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the INFINITT ULite used for?
The INFINITT ULite is designed for radiology applications, enabling healthcare professionals to view, interpret, and analyze medical images and clinical reports directly through a web browser or mobile device. It eliminates the need for dedicated software installation, allowing instant access to diagnostic data on any connected platform. This supports efficient workflows in radiology departments by providing a unified interface for image visualization and advanced diagnostic tools.
How is the INFINITT ULite supplied and accessed?
The INFINITT ULite is supplied as a software application accessible via web browsers or mobile devices. No local installation is required, making it a zero-footprint solution. Users can log in and access medical images and reports from any device with internet connectivity, ensuring flexibility and convenience in clinical settings.
Is the INFINITT ULite intended for sterile environments?
No, the INFINITT ULite is designed for use in non-sterile environments such as radiology departments or clinical workstations. Since it operates via web browsers or mobile devices, it does not require sterilization or direct contact with sterile fields, aligning with standard digital imaging workflows.
Is the INFINITT ULite single-use or reusable?
The INFINITT ULite is intended for single-use per session, meaning it is optimized for one diagnostic workflow at a time. However, the underlying platform may support multiple sessions depending on system configuration, allowing for repeated use across different diagnostic tasks as long as the device remains properly maintained and updated.
What regulatory approval does the INFINITT ULite hold?
The INFINITT ULite holds FDA 510(k) clearance under the classification K163290, determined to be substantially equivalent to a predicate device under the Radiology Advisory Committee. This clearance confirms its compliance with regulatory standards for digital imaging solutions, ensuring its suitability for use in radiology settings.