K232346
- 510(k) number
- K232346
- Device name
- Digital Expert Access with Remote Scanning
- Applicant
- GE Healthcare IL · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2023-10-27
- Date received
- 2023-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232346.pdf
Official FDA record: K232346
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.