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)
Aug 13, 2025GE Medical Systems, LLC
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK160618
K163331 +1
Jul 30, 2025Philips North America
Upgrade to MR 7700 Model Number (REF): 782130;
Open, Classified		 LNHNone listed
Jul 30, 2025Philips North America
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Open, Classified		 LNHNone listed
Jul 30, 2025Philips North America
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Open, Classified		 LNHNone listed
Jul 30, 2025Philips North America
SmartPath to dStream for 3.0T Model Number (REF): 782145;
Open, Classified		 LNHNone listed
Jul 30, 2025Philips North America
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
Open, Classified		 LNHK213516
K230972
Jul 30, 2025Philips North America
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Open, Classified		 LNHK212673
K223442
Jul 30, 2025Philips North America
Intera 3.0T Quasar Dual Model Number (REF): 781150;
Open, Classified		 LNHK193215
Jul 30, 2025Philips North America
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Open, Classified		 LNHK193215
K230972
Jul 30, 2025Philips North America
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Open, Classified		 LNHK193215
K230972
Jul 30, 2025Philips North America
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Open, Classified		 LNHK193215
K213583
Jul 30, 2025Philips North America
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Open, Classified		 LNHK193215
K213583
Jul 30, 2025Philips North America
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Open, Classified		 LNHK193215
K213516
Jul 30, 2025Philips North America
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Open, Classified		 LNHK193215
Jul 30, 2025Philips North America
Ingenia 1.5T S Model Number (REF): 781347;
Open, Classified		 LNHK193215
Jul 30, 2025Philips North America
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Open, Classified		 LNHK193215
K213583
Jul 30, 2025Philips North America
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Open, Classified		 LNHNone listed
Jul 30, 2025Philips North America
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Open, Classified		 LNHNone listed
Jul 30, 2025Philips North America
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Open, Classified		 LNHK193215
Jul 30, 2025Philips North America
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Open, Classified		 LNHK193215
Jul 18, 2025GE Medical Systems, LLC
SIGNA PET/MR
Open, Classified		 LNHNone listed
Jul 18, 2025GE Medical Systems, LLC
Discovery MR750w 3.0T
Open, Classified		 LNHNone listed
Jul 18, 2025GE Medical Systems, LLC
SIGNA Architect AIR
Open, Classified		 LNHNone listed
Jul 18, 2025GE Medical Systems, LLC
SIGNA Architect
Open, Classified		 LNHK160618
K163331 +1
Jun 9, 2025Philips North America
SmartPath to dStream for 1.5T; Product Number: 782146;
Open, Classified		 LNHNone listed
Jun 9, 2025Philips North America
Intera Achieva 1.5T Pulsar; Product Number: 781171;
Open, Classified		 LNHK193215
Jun 9, 2025Philips North America
Intera 1.5T Omni/Stellar; Product Number: 781104;
Open, Classified		 LNHK193215
Jun 9, 2025Philips North America
Intera 1.5T Master/Nova Product Number: 781106;
Open, Classified		 LNHK193215
Jun 9, 2025Philips North America
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Open, Classified		 LNHK193215
Jun 9, 2025Philips North America
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Open, Classified		 LNHK193215
Jun 9, 2025Philips North America
Intera 1.5T Achieva Nova Product Number: 781172;
Open, Classified		 LNHK193215
Jun 9, 2025Philips North America
Intera 1.5T Achieva IT Nova Product Number: 781175
Open, Classified		 LNHK193215
Jun 9, 2025Philips North America
Achieva XR Product Numbers: (1) 781153, (2) 781253;
Open, Classified		 LNHK193215
May 16, 2025Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Open, Classified		 LNHK213516
K230972
May 16, 2025Philips North America Llc
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Open, Classified		 LNHK212673
K223442
May 16, 2025Philips North America Llc
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Open, Classified		 LNHK193215
K230972
May 16, 2025Philips North America Llc
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Open, Classified		 LNHK193215
K230972
May 16, 2025Philips North America Llc
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Open, Classified		 LNHK193215
K213583
May 16, 2025Philips North America Llc
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Open, Classified		 LNHK193215
May 16, 2025Philips North America Llc
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Open, Classified		 LNHK193215
May 16, 2025Philips North America Llc
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Open, Classified		 LNHK193215
K213583
May 16, 2025Philips North America Llc
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Open, Classified		 LNHK193215
May 16, 2025Philips North America Llc
Product Name: Ingenia 1.5T S; Model Number: 781347;
Open, Classified		 LNHK193215
May 16, 2025Philips North America Llc
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Open, Classified		 LNHK193215
K213583
May 16, 2025Philips North America Llc
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Open, Classified		 LNHNone listed
May 16, 2025Philips North America Llc
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Open, Classified		 LNHNone listed
May 16, 2025Philips North America Llc
Product Name: Upgrade to MR 7700; Model Number: 782130;
Open, Classified		 LNHK213516
K230972
May 16, 2025Philips North America Llc
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Open, Classified		 LNHK162931
K173079 +1
May 16, 2025Philips North America Llc
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
Open, Classified		 LNHK162931
K173079 +1
May 16, 2025Philips North America Llc
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Open, Classified		 LNHK162931
K173079 +1

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