System, Nuclear Magnetic Resonance Imaging
FDA product code LNH · 1071 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1000
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1988-09-02 – 2026-09-16
LNH
2026-09-16
LNH
2026-09-16
APERTO Lucent MRI System
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LNH
2026-09-01
MAGNETOM Free.Max; MAGNETOM Free.Star
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LNH
2026-08-19
Swoop® Portable MR Imaging® System
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LNH
2026-08-17
MagicScan-1.5, GreenMR Serenity 1.5T
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LNH
2026-08-13
AIR Recon DL
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LNH
2026-07-31
I-Genius (100019400)
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LNH
2026-07-31
MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
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LNH
2026-05-22
uMR Astra
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LNH
2026-04-06
APERTO Lucent MRI System
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LNH
2026-03-27
S-scan Open (100001800)
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LNH
2026-03-27
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
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LNH
2026-03-20
nordicAudio (1.0)
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LNH
2026-03-13
Embrace Neonatal MRI System
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LNH
2026-03-09
LiverMultiScan (v6.0)
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LNH
2026-03-05
Magnifico Open (100009900)
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LNH
2026-02-23
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
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LNH
2026-02-23
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
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LNH
2026-02-06
SIGNA™ Bolt
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LNH
2026-02-05
SIGNA™ Sprint Select
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LNH
2026-01-26
Ascent3T Neonatal Magnetic Resonance Imaging System
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LNH
2025-12-23
AIR Recon DL
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LNH
2025-12-19
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
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LNH
2025-12-12
Swoop® Portable MR Imaging® System
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LNH
2025-11-20
MAGNETOM Free.Max; MAGNETOM Free.Star
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LNH
2025-09-25
uMR 680
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LNH
2025-09-17
ECHELON Synergy
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LNH
2025-09-11
SIGNA™ Sprint
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LNH
2025-09-09
MuscleView 2.0
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LNH
2025-08-21
Vista OS, Vista AI Scan, RTHawk
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LNH
2025-08-06
InVision™ 3T Recharge Operating Suite
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LNH
2025-08-05
uMR Jupiter
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LNH
2025-07-22
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
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LNH
2025-07-17
uMR Ultra
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LNH
2025-07-16
uMR 680
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LNH
2025-07-11
Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
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LNH
2025-06-16
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
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LNH
2025-06-16
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
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LNH
2025-06-05
Sonic DL
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LNH
2025-06-04
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
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LNH
2025-05-30
Swoop® Portable MR Imaging® System (V2)
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LNH
2025-05-21
Swoop® Portable MR Imaging® System
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LNH
2025-05-21
uMR Omega
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LNH
2025-03-17
SIGNA Prime Elite
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LNH
2025-02-12
SureWave Elastography (Q7000225)
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LNH
2025-01-17
Prenuvo Body Composition
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LNH
2025-01-07
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
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LNH
2024-12-23
NIDO Baby Magnetic Resonance Imaging System
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LNH
2024-12-06
SyMRI
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LNH
2024-11-26
MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
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LNH
2024-10-17
SIGNA MAGNUS
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LNH
2024-10-02
VitruvianScan (v1.0)
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LNH
2024-10-01
MuscleView
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LNH
2024-08-26
MyoStrain (6.0)
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LNH
2024-08-20
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
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LNH
2024-08-13
ECHELON Synergy MRI System
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LNH
2024-07-22
neo315
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LNH
2024-07-16
Swoop® Portable MR Imaging® System
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LNH
2024-06-26
Magnifico Open (100009900); Magnifico MSK ( 100009910)
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LNH
2024-05-10
APERTO Lucent MRI System
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LNH
2024-05-03
ECHELON Synergy V10.0
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LNH
2024-04-26
uMR Jupiter
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LNH
2024-04-12
OASIS MRI System
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LNH
2024-04-12
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
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LNH
2024-04-10
uMR 680
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LNH
2024-03-29
MAGNETOM Viato.Mobile
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LNH
2024-03-26
SyMRI
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LNH
2024-03-22
uMR Omega
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LNH
2024-03-22
MAGNETOM Terra; MAGNETOM Terra.X
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LNH
2024-02-29
MAGNETOM Cima.X Fit
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LNH
2024-02-15
InVision™ 1.5 Surgical Theatre
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LNH
2024-02-08
neuro42 MRI System
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LNH
2024-01-19
SIGNA Champion
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LNH
2023-12-22
MAGNETOM Sola; MAGNETOM Altea
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LNH
2023-12-18
MAGNETOM Cima.X
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LNH
2023-12-13
fMRI Hardware System
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LNH
2023-11-14
MAGNETOM Avanto fit; MAGNETOM Skyra fit
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LNH
2023-11-09
MAGNETOM Free.Max; MAGNETOM Free.Star
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LNH
2023-10-27
Digital Expert Access with Remote Scanning
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LNH
2023-10-23
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
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LNH
2023-10-11
Synq Software Version 1.3
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LNH
2023-10-06
Swoop® Portable MR Imaging System®
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LNH
2023-09-29
Terran NM-101
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LNH
2023-09-06
MAGNETOM Viato.Mobile
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LNH
2023-09-05
Promaxo MRI System II
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LNH
2023-08-30
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
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LNH
2023-08-02
Ingenia Elition R5.7.1 SP4 MR Systems
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LNH
2023-07-13
ECHELON Synergy MRI system
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LNH
2023-06-20
HepaFatSmart (V2.0.0)
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LNH
2023-05-30
Sonic DL
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LNH
2023-05-23
uMR Omega
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LNH
2023-05-18
uMR 570
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LNH
2023-04-28
Ingenia Elition and MR 7700 MR Systems
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LNH
2023-04-06
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
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LNH
2023-03-28
MAGNETOM Amira; MAGNETOM Sempra
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LNH
2023-03-20
MOBINEURO Alita Intraoperative MRI System
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LNH
2023-03-02
1.5T 24E Posterior Array
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LNH
2023-02-24
MAGNETOM Vida
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LNH
2023-02-22
Swoop® Portable MR Imaging System™
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LNH
2023-02-21
NEONA 1.5T MRI System
View details →No matching devices.
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