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 |
|---|---|---|---|
| K261283 | fujifilm corporation | APERTO Lucent MRI System | September 16, 2026 |
| K261758 | aspect imaging | Embrace Vision Neonatal MRI System | September 16, 2026 |
| K260758 | siemens shenzhen magnetic resonance | MAGNETOM Free.Max; MAGNETOM Free.Star | September 1, 2026 |
| K262622 | hyperfine | Swoop® Portable MR Imaging® System | August 19, 2026 |
| K254250 | xingaoyi medical equipment co | MagicScan-1.5, GreenMR Serenity 1.5T | August 17, 2026 |
| K253808 | ge medical systems | AIR Recon DL | August 13, 2026 |
| K260852 | siemens healthineers | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | July 31, 2026 |
| K261331 | esaote | I-Genius (100019400) | July 31, 2026 |
| 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 |