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)
Apr 17, 2024Philips North America Llc
MR 7700, Magnetic Resonance System.
Open, Classified		 LNHK213516
Apr 17, 2024Philips North America Llc
MR 5300, Magnetic Resonance System.
Open, Classified		 LNHK212673
Apr 17, 2024Philips North America Llc
Intera CV, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 3.0T Quasar Dual, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T R11, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T Power/Pulsar, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T Master/Nova, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.5T, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 1.0T Omni/Stellar, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Intera 0.5T Standard, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Ingenia Elition X, Magnetic Resonance System.
Open, Classified		 LNHK193215
K213516 +1
Apr 17, 2024Philips North America Llc
Ingenia Elition S, Magnetic Resonance System.
Open, Classified		 LNHK193215
K213516 +1
Apr 17, 2024Philips North America Llc
Ingenia Ambition X, Magnetic Resonance System.
Open, Classified		 LNHK193215
K213583
Apr 17, 2024Philips North America Llc
Ingenia Ambition S, Magnetic Resonance System.
Open, Classified		 LNHK193215
K213583
Apr 17, 2024Philips North America Llc
Ingenia 3.0T CX, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Ingenia 3.0T, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Ingenia 1.5T S, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Ingenia 1.5T CX, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Ingenia 1.5T, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
GYROSCAN T5-NT, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
GYROSCAN T5, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
GYROSCAN T10-NT, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
GYROSCAN ACS-NT, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
Evolution Upgrade 3.0T, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
Enterprise 1.5T, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
Achieva XR, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Achieva 3.0TX for PET, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
Achieva 3.0T for PET, Magnetic Resonance System.
Open, Classified		 LNHNone listed
Apr 17, 2024Philips North America Llc
Achieva 3.0T, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Achieva 1.5T Initial, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Achieva 1.5T Conversion, Magnetic Resonance System.
Open, Classified		 LNHK193215
Apr 17, 2024Philips North America Llc
Achieva 1.5T, Magnetic Resonance System.
Open, Classified		 LNHK193215
Mar 4, 2024Canon Medical System, USA, INC.
Vantage Titan, Model: MRT-1504
Open, Classified		 LNHK122613
Mar 4, 2024Canon Medical System, USA, INC.
MRI system: Vantage Elan, Model: MRT-2020
Open, Classified		 LNHK210164
Mar 4, 2024Canon Medical System, USA, INC.
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Open, Classified		 LNHK222968
Feb 2, 2024Philips North America
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Open, Classified		 LNHK181479
K183063 +1
Feb 2, 2024Philips North America
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Open, Classified		 LNHK173356
K173451
Feb 2, 2024Philips North America
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Open, Classified		 LNHK153324
Jan 25, 2024Philips North America
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Open, Classified		 LNHK193215
Jan 25, 2024Philips North America
Intera 1.5T, Model No. 781195
Open, Classified		 LNHK193215
Dec 14, 2023Philips North America Llc
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
Open, Classified		 LNHK041602
K052078 +1
Nov 21, 2023Philips North America Llc
SmartPath to dStream for 1.5T
Open, Classified		 LNHNone listed
Nov 21, 2023Philips North America Llc
Intera 1.5T Power/Pulsar
Open, Classified		 LNHK162931

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