K231133
- 510(k) number
- K231133
- Device name
- neo315
- Applicant
- Neoscan Solution GmbH DE
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-07-22
- Date received
- 2023-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K231133.pdf
Official FDA record: K231133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.