NEURO II-SE, MODELS OR-MB-DR AND OR-DR— 510(k) K061916
Substantially EquivalentImris, Inc.
FDA 510(k) clearance K061916 for NEURO II-SE, MODELS OR-MB-DR AND OR-DR, Substantially Equivalent on 2006-08-11. 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 K061916
K-number listed on FDA's recall record- Z-1098-2016 — Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
- Z-0428-2013 — IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061916.
Data sourced from openFDA. This site is unofficial and independent of the FDA.