System, Nuclear Magnetic Resonance Spectroscopic

Device Code: 5389

Product Code(s): LNI

Device Classification Information

Device Type ID5389
Device NameSystem, Nuclear Magnetic Resonance Spectroscopic
Regulation DescriptionMagnetic Resonance Diagnostic Device.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.1000 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLNI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5389
DeviceSystem, Nuclear Magnetic Resonance Spectroscopic
Product CodeLNI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMagnetic Resonance Diagnostic Device.
CFR Regulation Number892.1000 [🔎]
TPLC Last Update: 2019-04-02 21:05:23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.