K261331
- 510(k) number
- K261331
- Device name
- I-Genius (100019400)
- Applicant
- Esaote, S.p.A. IT
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-07-31
- Date received
- 2026-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K261331.pdf
Official FDA record: K261331
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.