ClearanceBrief
Panels › Radiology › Product code LNH · Class 2

System, Nuclear Magnetic Resonance Imaging

Regulation 892.1000

28510(k)s in 12 months (1,110 all time)
60recalls in 12 months (723 all time)
630recalls that name a 510(k)
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Top companies in LNH

Company510(k)sRecalls
Philips North America0236
Siemens Medical Solutions13661
GE Medical Systems8280
GE Healthcare5123
Hitachi Medical Systems America, Inc.5423
Philips Medical Systems Nederlands B.V.367
Toshiba America Mri, Inc.620
Philips Medical Systems (Cleveland), Inc.574
Philips Medical Systems Nederland B.V.2714
Medical Advances, Inc.380
DateFirm and productCodeLinked 510(k)
Sep 25, 2026Philips North America
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), 6. 782143 (3.0T), 7. 782162 (3.0T); Sof
Open, Classified		 LNHK213583
K223458 +2
Sep 25, 2026Philips North America
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK230972
Sep 25, 2026Philips North America
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK213516
Sep 25, 2026Philips North America
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK223458
K251397
Sep 25, 2026Philips North America
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. 781260 (1.5T), 2. 782112 (1.5T), 3. 7821
Open, Classified		 LNHK110151
K213583 +2
Sep 25, 2026Philips North America
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK213516
K223458 +2
Sep 25, 2026Philips North America
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK223442
K223458 +2
Sep 25, 2026Philips North America
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. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10.
Open, Classified		 LNHK193215
K213516 +4
Sep 25, 2026Philips North America
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. 782109 (X), 8. 782138 (X), 9. 782160 (X), 1
Open, Classified		 LNHK183063
K193215 +4
Sep 25, 2026Philips North America
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;
Open, Classified		 LNHK183063
K251808
Sep 25, 2026Philips North America
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 (1.5T CX), 7. 781347 (1.5T S); Software Versi
Open, Classified		 LNHK183063
K193215 +1
Sep 25, 2026Philips North America
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Open, Classified		 LNHK223458
K251397
Sep 18, 2026Philips North America Llc
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (
Open, Classified		 LNHK110151
K193215 +4
Sep 18, 2026Philips North America Llc
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Open, Classified		 LNHK213516
K230972
Sep 18, 2026Philips North America Llc
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Open, Classified		 LNHK193215
K223442 +1
Sep 18, 2026Philips North America Llc
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 1.5T Achieva Nova-Dual (781173), 6. Inte
Open, Classified		 LNHK030520
K052013 +1
Sep 18, 2026Philips North America Llc
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
Open, Classified		 LNHK183063
K193215 +4
Sep 18, 2026Philips North America Llc
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Open, Classified		 LNHK183063
K193215 +1
Sep 18, 2026Philips North America Llc
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Open, Classified		 LNHK183063
K193215 +2
Sep 18, 2026Philips North America Llc
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 7812
Open, Classified		 LNHK183063
K193215 +1
Sep 18, 2026Philips North America Llc
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Open, Classified		 LNHK213583
K251808
Sep 18, 2026Philips North America Llc
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Open, Classified		 LNHK052078
Sep 18, 2026Philips North America Llc
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Open, Classified		 LNHK052013
K052078 +1
Sep 18, 2026Philips North America Llc
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 (Achieva 1.5T Conversion), 4. 781346 (Achieva
Open, Classified		 LNHK052013
K052078 +3
Apr 27, 2026Philips North America
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Open, Classified		 LNHK213516
K213583 +2
Apr 27, 2026Philips North America
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Open, Classified		 LNHK193215
K213583 +1
Apr 27, 2026Philips North America
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Open, Classified		 LNHK193215
K213583 +2
Apr 27, 2026Philips North America
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Open, Classified		 LNHK213583
Apr 27, 2026Philips North America
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
Open, Classified		 LNHK183063
K193215 +1
Apr 27, 2026Philips North America
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Open, Classified		 LNHK223458
K230972 +1
Apr 27, 2026Philips North America
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972,
Open, Classified		 LNHK213516
K251808
Apr 27, 2026Philips North America
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
Open, Classified		 LNHK223458
K230972 +2
Apr 27, 2026Philips North America
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
Open, Classified		 LNHK193215
K213583 +3
Apr 27, 2026Philips North America
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Open, Classified		 LNHK193215
K213583
Apr 27, 2026Philips North America
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Open, Classified		 LNHK173079
K251808
Apr 27, 2026Philips North America
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215
Open, Classified		 LNHK223458
K251397 +1
Apr 27, 2026Philips North America
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Open, Classified		 LNHK183063
Apr 27, 2026Philips North America
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K
Open, Classified		 LNHK163116
K173079 +3
Apr 27, 2026Philips North America
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
Open, Classified		 LNHK213583
K223458
Apr 27, 2026Philips North America
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
Open, Classified		 LNHK193215
K213583 +3
Apr 27, 2026Philips North America
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Open, Classified		 LNHK193215
Apr 27, 2026Philips North America
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Open, Classified		 LNHK173079
Apr 27, 2026Philips North America
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Open, Classified		 LNHK190461
K193215
Apr 2, 2026GE Healthcare LLC
SIGNA Premier systems
Open, Classified		 LNHK171128
K183231 +1
Jan 29, 2026Philips North America
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK183063
Jan 29, 2026Philips North America
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK213583
Jan 29, 2026Philips North America
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK213516
K223442 +1
Jan 29, 2026Philips North America
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK213516
K230972
Jan 29, 2026Philips North America
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK193215
K230972
Jan 29, 2026Philips North America
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK193215
K230972

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