NORDICICE SOFTWARE— 510(k) K082441
Substantially EquivalentNordicimaginglab AS
FDA 510(k) clearance K082441 for NORDICICE SOFTWARE, Substantially Equivalent on 2008-11-21. Applicant: Nordicimaginglab AS. Device class: 2.
Clearance details
- Applicant
- Nordicimaginglab AS
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bergen, Hordaland, NO
Recent devices under product code LLZ
view allMore clearances from Nordicimaginglab AS
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 K082441
K-number listed on FDA's recall record- Z-2061-2018 — nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
- Z-2044-2018 — nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082441.
Data sourced from openFDA. This site is unofficial and independent of the FDA.