Intelepacs, Model Version 3.X.X
by Intelerad Medical Systems Incorporated Canada EUDAMED510(k)
510(k) K083520
Product code LLZ
Overview
Intelerads, Model Version 3.X.X, is a Picture Archiving and Communication System (PACS) designed for the digital storage, retrieval, and distribution of medical imaging data. It facilitates seamless integration with radiology workflows, enabling efficient image management across healthcare facilities.
This system is supplied as software and operates within radiology departments, hospitals, or clinical settings. It is intended for use in environments requiring high-capacity image storage and secure, multi-user access. The device is not single-use or reusable and does not require sterility. Authorisations include FDA 510K clearance and MDR compliance, with regulatory filing under K083520.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK083520 | Date23 Jun 2009 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Recalls
-
- Terminated Z-2267-2014
In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.
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 Intelerad Medical Systems Incorporated
Questions
What type of healthcare environment is INTELEPACS, Model Version 3.X.X, designed to operate in and what does it do?
INTELEPACS, Model Version 3.X.X, is a Picture Archiving and Communication System (PACS) designed specifically for radiology departments, hospitals, or clinical settings that require digital management of medical imaging. It provides high-capacity storage, secure multi-user access, and seamless integration with radiology workflows to streamline the storage, retrieval, and distribution of medical imaging data. Since it is software-based, it does not require physical installation in a sterile environment or have single-use/reuse constraints.
How is INTELEPACS, Model Version 3.X.X, supplied, and does it require any special handling like sterilization?
INTELEPACS is supplied as software and does not require physical packaging, sterilization, or single-use/reuse considerations. It is installed and operated within radiology IT infrastructure, meaning it is not a consumable or reusable device—it is a standalone system designed for continuous use in digital imaging workflows. No special handling beyond standard software deployment applies.
What regulatory pathways has INTELEPACS, Model Version 3.X.X, followed, and what does that mean for its use?
INTELEPACS has undergone FDA 510(k) clearance (under K083520) and MDR compliance, confirming it meets regulatory standards for digital radiology systems in the U.S. and EU markets. The Radiology Advisory Committee (RA) reviewed its substantial equivalence to a predicate device, ensuring it aligns with existing safety and performance expectations for PACS systems. This means it is approved for use in clinical settings where digital image management is required, but the exact regulatory status (e.g., FDA clearance or CE marking) should be verified based on the jurisdiction.
Does INTELEPACS support multiple users simultaneously, and how does it ensure data security?
Yes, INTELEPACS is explicitly designed for multi-user access, enabling multiple clinicians to retrieve, store, and share medical imaging data simultaneously within authorized radiology workflows. While the provided data does not detail specific security protocols, its regulatory compliance (FDA 510(k) and MDR) implies adherence to industry standards for data integrity, access controls, and secure transmission—critical for healthcare environments handling sensitive imaging information. Always verify your institution’s IT policies for additional security measures.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K083520
- EUDAMED