iSite Radiology
by Stentor, Inc. 510(k)
Active
510(k) K013630
Overview
The iSite Radiology is a diagnostic reading workstation classified as a radiology information system (product code LLZ). It functions as a software-based platform designed to receive, process, and display digital medical images for radiologic assessment, supporting diagnostic workflows in radiology departments.
This device operates on standard off-the-shelf PC hardware and interfaces with remote Stentor iSite servers via TCP/IP networks to receive DICOM images. It converts images into viewable formats, including JPEG and wavelet compression, while providing tools for diagnostic review such as image scaling, annotation, measurement, and cine-loop playback. Supplied as a software solution, it is intended for use in radiology settings and holds FDA 510(k) clearance under the traditional review pathway (K013630).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013630 | Date5 Dec 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Stentor, Inc.
Questions
What types of medical images can the iSite Radiology workstation display and process for diagnostic review?
The iSite Radiology workstation is designed to receive, process, and display digital medical images in formats compatible with DICOM (Digital Imaging and Communications in Medicine) standards. It supports standard diagnostic workflows by converting images into viewable formats like JPEG and wavelet compression. The platform includes tools for radiologic assessment, such as image scaling, annotation, measurements, and cine-loop playback, ensuring comprehensive diagnostic evaluation across radiology settings.
How is the iSite Radiology workstation installed and deployed in a clinical environment?
The iSite Radiology is supplied as a software-based solution that operates on standard off-the-shelf PC hardware. It connects to remote Stentor iSite servers via TCP/IP networks to retrieve DICOM images, making it a flexible, network-dependent tool for radiology departments. No physical hardware installation is required beyond the PC infrastructure, as the software integrates directly into existing IT environments.
Is the iSite Radiology workstation intended for single-use or repeated use in a radiology department?
Since the iSite Radiology is a software-based platform installed on PC hardware, it is designed for repeated use within radiology departments. There is no physical consumable component, and the software remains functional across multiple diagnostic sessions as long as the underlying hardware and network connectivity are maintained.
What regulatory pathway was followed for the FDA clearance of the iSite Radiology workstation?
The iSite Radiology received FDA clearance through the traditional 510(k) review pathway (K013630) under the Radiology advisory committee (RA). The device was determined to be substantially equivalent to a legally marketed predicate, ensuring compliance with FDA requirements for diagnostic radiology information systems (product code LLZ).