LNH — System, Nuclear Magnetic Resonance Imaging Class II
FDA product code LNH covers "System, Nuclear Magnetic Resonance Imaging", a Class II medical device regulated under 21 CFR 892.1000. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260113 | shanghai united imaging healthcare co | uMR Astra | May 22, 2026 |
| K253862 | fujifilm corporation | APERTO Lucent MRI System | April 6, 2026 |
| K253625 | canon medical systems corporation | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing | March 27, 2026 |
| K260746 | esaote | S-scan Open (100001800) | March 27, 2026 |
| K251937 | nordicneurolab | nordicAudio (1.0) | March 20, 2026 |
| 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 |