IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO— 510(k) K101813
Substantially EquivalentImris, Inc.
FDA 510(k) clearance K101813 for IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO, Substantially Equivalent on 2010-10-05. Applicant: Imris, Inc.. Device class: 2.
Clearance details
- Applicant
- Imris, Inc.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code LNH
view allMore clearances from Imris, Inc.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101813
K-number listed on FDA's recall record- Z-0161-2026 — IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
- Z-0162-2026 — IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
- Z-0163-2026 — IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
- Z-0164-2026 — IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
- Z-0762-2020 — iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a solution providing MRI scanning capabilities in the angiography room while retaining all functionality of Siemens Artis zee system. The System includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside RF room to facilitate intra-operative, interventional, and multi-room imaging. It also allows intra-operative or interventional imaging capabilities, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room. The iMRX system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventionsa procedures. The iMRX system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101813.
Data sourced from openFDA. This site is unofficial and independent of the FDA.