Myrian 1.11
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Intrasense
Identifiers
- 510(k) Number
- K113620 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)
Myrian 1.11 is a medical imaging software device designed for reviewing and managing images from standard medical imaging modalities. It supports DICOM communication, media interchange (including printing, CD burning, and storage), and reporting functionalities to streamline diagnostic workflows.
The device is supplied as a software platform for use in radiology settings and is intended for single-use sessions per installation. It adheres to FDA 510(k) clearance (K113620) and MDD compliance, with no explicit sterility or reusable designation. No MRI safety classification or size specifications are provided in the regulatory data.
Frequently asked questions
What types of medical imaging modalities does the Myrian 1.11 software support for reviewing and managing images?
The Myrian 1.11 software is designed to support standard medical imaging modalities through DICOM communication, enabling it to handle images from various sources like X-ray, CT, MRI, and ultrasound systems. This compatibility allows radiology workflows to be streamlined by integrating and managing images from these different modalities within a single platform.
Is the Myrian 1.11 software intended for reuse across multiple patient sessions, or is it meant for single-use per installation?
The Myrian 1.11 software is specified for single-use sessions per installation, meaning it is intended to be used for one diagnostic workflow or session at a time. This distinction is important for managing software licenses, updates, and ensuring compliance with regulatory guidelines for its intended use in radiology settings.
How does the Myrian 1.11 software facilitate workflow efficiency in radiology departments?
Myrian 1.11 enhances workflow efficiency by providing DICOM communication for seamless image transfer, media interchange capabilities (such as printing, CD burning, and storage), and reporting functionalities. These features allow radiologists to review, organize, and distribute images and reports more effectively, reducing manual processes and improving diagnostic turnaround time.
What regulatory pathways has the Myrian 1.11 software followed for approval, and which advisory committee was involved?
The Myrian 1.11 software underwent FDA clearance through a traditional 510(k) process, specifically under the product code LLZ, which falls under the Radiology category. The review was conducted by the Radiological Devices Advisory Committee (RA), and the clearance was granted on July 12, 2012, with the decision code SESE (Substantially Equivalent). Additionally, it complies with the Medical Device Directive (MDD).
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: MYRIAN 1.11 by INTRASENSE | FDA 510 (k) Summary, Platform Myrian® | Medical Imaging Software | Intrasense, Intrasense | Visualization Software | Platform Myrian®, Intrasense Myrian 1.11 - allmed.wiki
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K113620 | Class II | Active |
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Manufacturer
- Manufacturer
- Intrasense
Sources (2)
- FDA 510(k) K113620 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026