LNH — System, Nuclear Magnetic Resonance Imaging Class II
FDA Device Classification
Classification Details
- Product Code
- LNH
- Device Class
- Class II
- Regulation Number
- 892.1000
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K254277 | aspect imaging | Embrace Neonatal MRI System | March 13, 2026 |
| K253413 | perspectum | LiverMultiScan (v6.0) | March 9, 2026 |
| K251901 | esaote | Magnifico Open (100009900) | March 5, 2026 |
| K253648 | philips medical systems nederland | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q | February 23, 2026 |
| K260265 | siemens shenzhen magnetic resonance | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | February 23, 2026 |
| K253780 | ge medical systems | SIGNA Bolt | February 6, 2026 |
| K253779 | ge medical systems | SIGNA Sprint Select | February 5, 2026 |
| K253499 | eyas medical imaging | Ascent3T Neonatal Magnetic Resonance Imaging System | January 26, 2026 |
| K252379 | ge medical systems | AIR Recon DL | December 23, 2025 |
| K252838 | siemens healthcare | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO | December 19, 2025 |
| K253489 | hyperfine | Swoop® Portable MR Imaging® System | December 12, 2025 |
| K251822 | siemens shenzhen magnetic resonance | MAGNETOM Free.Max; MAGNETOM Free.Star | November 20, 2025 |
| K252371 | shanghai united imaging healthcare co | uMR 680 | September 25, 2025 |
| K251386 | fujifilm corporation | ECHELON Synergy | September 17, 2025 |
| K251399 | ge medical systems | SIGNA Sprint | September 11, 2025 |
| K251682 | springbok, inc. (dba springbok analytics) | MuscleView 2.0 | September 9, 2025 |
| K251029 | vista ai | Vista OS, Vista AI Scan, RTHawk | August 21, 2025 |
| K252239 | imris imaging | InVision 3T Recharge Operating Suite | August 6, 2025 |
| K250246 | shanghai united imaging healthcare co | uMR Jupiter | August 5, 2025 |
| K250901 | canon medical systems corporation | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing | July 22, 2025 |