510(k) K253862
- Device
- APERTO Lucent MRI System
- Applicant
- Fujifilm Corporation
- 510(k) number
- K253862
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-06
- Date received
- 2025-12-03
- Regulation
- 892.1000
- Classification name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Chaitrali Kulkarni
- Address
- 26-30, Nishiazabu 2-Chome Minato-Ku JP 106-8620 106-8620
FDA Registration Numbers
- 3008447096
- 3005877899
- 3005049692
- 3008986341
- 3011657336
- 1932738
- 3021059265
- 3032109181
- 3003661577
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- 3004859018
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- 3009714754
- 3026047529
Source Documents
Other 510(k) Records For Product Code LNH
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|---|---|---|---|
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2026-03-27 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026-03-09 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026-03-05 |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | 2026-02-23 |
| K253780 | SIGNA Bolt | Ge Medical Systems, LLC | 2026-02-06 |
| K253779 | SIGNA Sprint Select | Ge Medical Systems, LLC | 2026-02-05 |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | 2026-01-26 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | 2025-12-19 |
| K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-12-12 |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 |