K243209
- 510(k) number
- K243209
- Device name
- nordicMEDiVA
- Applicant
- Nordicneurolab AS NO
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-10-22
- Date received
- 2024-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K243209.pdf
Official FDA record: K243209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.