Altris IMS System
by Altris, Inc. United States EUDAMED510(k)
510(k) K232088
Product code NFJ
Overview
The Altris IMS System is an Image Management System for Ophthalmic Use, designed to facilitate the storage, retrieval, and sharing of ophthalmic imaging data. Classified as a Class II medical device, it integrates with diagnostic imaging modalities to enhance workflow efficiency in radiology and ophthalmology settings, ensuring secure and organized digital management of diagnostic images.
This system is supplied as a reusable, non-sterile device intended for use in clinical environments where ophthalmic imaging is performed. It operates within MRI-safe conditions and is authorized under FDA 510(k) clearance (K232088) and the EU MDR. The device is regulated under the U.S. regulation number 892.2050 and is distributed by Altris, Inc., based in Chicago, Illinois.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK232088 | Date31 Jul 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- Full name
- Altris IMS
- 510(k) Number
- FDA Product Code
- NFJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Altris, Inc.
Questions
What is the primary purpose of the Altris IMS System in a clinical setting?
The Altris IMS System is designed to streamline ophthalmic imaging workflows by securely storing, retrieving, and sharing diagnostic images. It integrates with existing imaging modalities to improve efficiency in radiology and ophthalmology departments, ensuring organized digital management of visual data for better clinical decision-making.
Is the Altris IMS System reusable or single-use, and what are its sterility requirements?
The Altris IMS System is supplied as a reusable, non-sterile device. Since it operates in clinical environments but does not directly interface with patients, sterility is not a requirement—proper cleaning and maintenance protocols must be followed to ensure safe reuse across multiple imaging sessions.
How does the Altris IMS System ensure compatibility with existing ophthalmic imaging equipment?
The system is explicitly designed to integrate with diagnostic imaging modalities used in ophthalmology, though the exact supported devices aren’t detailed in the data. Its classification as an Image Management System for Ophthalmic Use implies compatibility with common imaging tools in radiology and eye care settings, enhancing workflow efficiency without requiring specialized hardware.
What regulatory pathways has the Altris IMS System undergone, and where is it authorized for use?
The system holds FDA 510(k) clearance (K232088) under the Traditional pathway, with a decision of *Substantially Equivalent* to a predicate device, and is also authorized under the EU Medical Device Regulation (MDR). It is regulated under U.S. code 21 CFR 892.2050 and distributed by Altris, Inc. in Chicago, Illinois.
Does the Altris IMS System operate in MRI-safe environments, and if so, why might that matter?
Yes, the Altris IMS System is MRI-safe, meaning it can be used in proximity to MRI machines without interfering with imaging or posing risks to patients. This is critical in hybrid ophthalmology/radiology settings where both imaging modalities may be used in close proximity, ensuring seamless integration without safety concerns.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K232088
- EUDAMED