System, Nuclear Magnetic Resonance Spectroscopic

Product Code: LNI

Radiology Nuclear Magnetic Resonance Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1000


Radiation TypeMicrowave EMF
Radition SafetyNone
Annual ReportsNo

Products Classified as LNI

5389System, Nuclear Magnetic Resonance SpectroscopicMagnetic Resonance Diagnostic Device.

Total Product Life Cycle (TPLC) Devices

5389System, Nuclear Magnetic Resonance SpectroscopicMagnetic Resonance Diagnostic Device.

FDA Consensus Standards

System, Nuclear Magnetic Resonance Spectroscopic [37168]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [37048]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [35654]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [34007]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [33534]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [38515]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [32083]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [29948]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [33533]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [33531]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [33541]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Spectroscopic [33530]21 CFR §892.1000 🔎

Pre-market Notifications for LNI

K093044OASIS MRI SYSTEMHITACHI MEDICAL SYSTEMS AMERICA, INC.
K071506ECHELON SPECTROSCOPY PACKAGEHITACHI MEDICAL SYSTEMS AMERICA, INC.
K011604PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRIGE MEDICAL SYSTEMS, INC.
K010129EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K003575MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEMGE MEDICAL SYSTEMS
K991568MR SPECTROSCOPY PACKAGEPHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K970005GYREX 2T-PRESTIGEELSCINT, INC.
K962627CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEMSIEMENS MEDICAL SOLUTIONS USA, INC.
K930265HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HTGE MEDICAL SYSTEMS

Global Unique Device Identification Database

00884838068445System, nuclear magnetic resonance spectroscopic
00884838055322System, nuclear magnetic resonance spectroscopic
00884838055292System, nuclear magnetic resonance spectroscopic
04580292768186System, Nuclear Magnetic Resonance Spectroscopic
04056869044682System, nuclear magnetic resonance spectroscopic
04056869044521System, nuclear magnetic resonance spectroscopic
04056869023076System, nuclear magnetic resonance spectroscopic
04056869022956System, nuclear magnetic resonance spectroscopic
04056869022680System, nuclear magnetic resonance spectroscopic
04056869015569System, nuclear magnetic resonance spectroscopic
04056869015545System, nuclear magnetic resonance spectroscopic
04056869015538System, nuclear magnetic resonance spectroscopic
04056869015507System, nuclear magnetic resonance spectroscopic
04056869015491System, nuclear magnetic resonance spectroscopic
04056869015484System, nuclear magnetic resonance spectroscopic

Maude Adverse Events

OASIS HIGH-FIELD BORE-LESS MRHITACHI MEDICAL SYSTEMS AMERICA, INC.2015-01-07
CONCERTO CRT-D DR ATMEDTRONIC S.A.2012-10-15
TRIMA ACCEL ENHANCED PLT, PLS, RBC SETTERUMO BCT2012-06-15
TRIMA ACCELL ENHANCED PLT, PLS, RBC SETCARIDIANBCT2012-05-03
TRIMA ACCEL ENHANCED PLT, PLS, SETCARIDIANBCT2012-04-26
TRIMA ACCEL ENHANCED PLT, PLS, RBC SETCARIDIANBCT2012-04-26
TRIMA ACCEL ENHANCED PLT, PLS, RBC SETCARIDIANBCT2012-04-17
TRIMA ACCEL ENHANCED PLT, PLS, RBC SETCARIDIANBCT2012-02-08
TRIMA ACCEL ENHANCED PLT, PLS, RBC SETCARIDIANBCT2011-12-19

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