K252239
- 510(k) number
- K252239
- Device name
- InVision 3T Recharge Operating Suite
- Applicant
- Imris Imaging, Inc. MN · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-08-06
- Date received
- 2025-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252239.pdf
Official FDA record: K252239
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.