K230187
- 510(k) number
- K230187
- Device name
- Terran NM-101
- Applicant
- Terran Biosciences, Inc. NY · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2023-09-29
- Date received
- 2023-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230187.pdf
Official FDA record: K230187
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.