Device type
System, Nuclear Magnetic Resonance Imaging
Product code LNH · Class II · 21 CFR 892.1000 · Radiology
Recent 510(k)s
Oct 9, 2026
K262902
ECHELON Synergy
Fujifilm Corporation
- LNH
- Class II
Oct 7, 2026
K260092
Vista AI Scan
Vista AI, Inc.
- LNH
- Class II
Oct 1, 2026
K261612
SwiftSight-BodyComposition
Airs Medical, Inc.
- LNH
- Class II
Sep 16, 2026
K261758
Embrace Vision Neonatal MRI System
Aspect Imaging, Ltd.
- LNH
- Class II
Sep 16, 2026
K261283
APERTO Lucent MRI System
Fujifilm Corporation
- LNH
- Class II
Sep 1, 2026
K260758
MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd.
- LNH
- Class II
Aug 19, 2026
K262622
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
- LNH
- Class II
Aug 17, 2026
K254250
MagicScan-1.5, GreenMR Serenity 1.5T
Xingaoyi Medical Equipment Co.,Ltd
- LNH
- Class II
Recent recalls
Oct 7, 2026
Z-3314-2026
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1.…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3313-2026
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3308-2026
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3318-2026
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T),…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3316-2026
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3312-2026
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3315-2026
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3307-2026
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3310-2026
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 78…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3311-2026
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 7821…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3317-2026
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3309-2026
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3240-2026
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera…
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3233-2026
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3232-2026
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achi…
Philips North America Llc
- LNH
- Class II
- Ongoing