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Panels › Radiology › Product code LNI · Class 2

System, Nuclear Magnetic Resonance Spectroscopic

Regulation 892.1000

0510(k)s in 12 months (10 all time)
0recalls in 12 months (17 all time)
15recalls that name a 510(k)
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Top companies in LNI

Company510(k)sRecalls
Philips North America017
GE Medical Systems40
Hitachi Medical Systems America, Inc.20
Elscint, Inc.10
Philips Medical Systems (Cleveland), Inc.10
Siemens Medical Solutions USA, Inc.10
Toshiba America Medical Systems, In.C10
DateFirm and productCodeLinked 510(k)
Feb 1, 2024Philips North America
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Open, Classified		 LNINone listed
Feb 1, 2024Philips North America
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Open, Classified		 LNINone listed
Feb 1, 2024Philips North America
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Open, Classified		 LNIK213516
Feb 1, 2024Philips North America
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Achieva XR. Model (REF) Numbers 781153, 781253.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
Open, Classified		 LNIK193215
Feb 1, 2024Philips North America
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Open, Classified		 LNIK193215
Jan 25, 2024Philips North America
Ingenia Ambition X, Model No. 782109
Open, Classified		 LNIK193215
Jan 25, 2024Philips North America
Achieva 3.0T, Model No. 781177
Open, Classified		 LNIK193215
Jan 25, 2024Philips North America
Achieva 1.5T Conversion, Model No. 781283
Open, Classified		 LNIK193215
Jan 25, 2024Philips North America
Achieva 1.5T, Model No. 781178, 781196, 781296
Open, Classified		 LNIK193215
Jan 11, 2024Philips North America
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Open, Classified		 LNIK213583

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