NORDICBRAINEX— 510(k) K133910
Substantially EquivalentNordicneurolab
FDA 510(k) clearance K133910 for NORDICBRAINEX, Substantially Equivalent on 2014-04-04. Applicant: Nordicneurolab. Device class: 2.
Clearance details
- Applicant
- Nordicneurolab
- 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, NO
Recent devices under product code LLZ
view allMore clearances from Nordicneurolab
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 K133910
K-number listed on FDA's recall record- Z-1462-2022 — nordicBrainEX, software versions 2.21 through 2.3.10
- Z-2050-2018 — nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133910.
Data sourced from openFDA. This site is unofficial and independent of the FDA.