K232981
- 510(k) number
- K232981
- Device name
- Synq Software Version 1.3
- Applicant
- Synaptive Medical, Inc. CA
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2023-10-11
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K232981.pdf
Official FDA record: K232981
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.