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

Decided510(k)Device and applicantCode
Nov 24, 1995K942604SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
GE Medical Systems
LNH
Nov 14, 1995K954355ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
General Electric Co.
LNH
Nov 14, 1995K951650CLINICAL PROTON SPECTROSCOPY OPTION
Siemens Medical Solutions USA, Inc.
LNH
Nov 9, 1995K951681QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
Fonar Corp.
LNH
Oct 23, 1995K953248IRIS BILATERAL TMJ
Hitachi Medical Systems America, Inc.
LNH
Oct 17, 1995K953262QD BILATERAL BREAST COIL
Hitachi Medical Systems America, Inc.
LNH
Oct 7, 1995K945517MAGNETOM VISION (PROJECT 016)
Siemens Medical Solutions USA, Inc.
LNH
Oct 6, 1995K943440PROFILE 7000 C-SPINE COIL
Us Asia Instruments, Inc.
LNH
Sep 19, 1995K945791GYRES 2T PRESTIGE
Elscint, Inc.
LNH
Sep 18, 1995K945827OUTLOOK
Philips Medical Systems (Cleveland), Inc.
LNH
Sep 12, 1995K953918MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Hitachi Medical Systems America, Inc.
LNH
Aug 30, 1995K944724HEALTH IMAGE INC. HI STAR
Health Images, Inc.
LNH
Aug 23, 1995K945779MAGNETOM VISION (PROJECT 016)
Siemens Medical Solutions USA, Inc.
LNH
Aug 9, 1995K945730SIGNA PROFILE
GE Medical Systems
LNH
Aug 9, 1995K943189MEDRAD QWIK-FIX MRI DISPOSABLE KIT
Medrad, Inc.
LNH
Jul 24, 1995K952530HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE
Philips Medical Systems (Cleveland), Inc.
LNH
Jul 20, 1995K944228HEALTH IMAGES, INC. HI-STANDARD
Health Images, Inc.
LNH
Jun 26, 1995K952235MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15
Medrad, Inc.
LNH
Jun 26, 1995K952232MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15
Medrad, Inc.
LNH
Jun 22, 1995K951649MODEL #801GE1500 PEDIATRIC ARRAY COIL
Medic, Inc.
LNH
Jun 19, 1995K944070ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING
Advanced Nmr Systems, Inc.
LNH
Jun 19, 1995K941666SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS
General Electric Co.
LNH
Jun 13, 1995K944979MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
GE Medical Systems
LNH
Jun 5, 1995K946085THIN-FILM CARDIAC GATING CABLE
General Electric Co.
LNH
May 24, 1995K945155AIRIS
Hitachi Medical Systems America, Inc.
LNH
May 12, 1995K943798MRH-1500
Hitachi Medical Systems America, Inc.
LNH
May 11, 1995K950973MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
LNH
Apr 20, 1995K945875MRT-50 QD BODY COIL
Toshiba America Mri, Inc.
LNH
Apr 12, 1995K945828ECHO PLANAR IMAGING I
Philips Medical Systems (Cleveland), Inc.
LNH
Apr 10, 1995K940772ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
Fonar Corp.
LNH
Apr 6, 1995K945798MRT-35A UPGRADE 8.0CD
Toshiba America Mri, Inc.
LNH
Apr 6, 1995K945665FLEXART(TM) QD C-SPINE COIL
Toshiba America Mri, Inc.
LNH
Mar 23, 1995K945778PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
Medical Advances, Inc.
LNH
Mar 21, 1995K945386STRATIS
Hitachi Medical Systems America, Inc.
LNH
Feb 9, 1995K945397ANGIO II
Philips Medical Systems (Cleveland), Inc.
LNH
Feb 8, 1995K946244ACCESS(TM) COMPASS BED
Toshiba America Mri, Inc.
LNH
Feb 2, 1995K942669SMT-50CX/H
Shimadzu Medical Systems
LNH
Jan 26, 1995K941864MRT-150A, MRT-150A SOFTWARE VERSION 11.9
Toshiba America Mri, Inc.
LNH
Jan 26, 1995K941622ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION
Siemens Medical Solutions USA, Inc.
LNH
Jan 25, 1995K944773MODEL 405GE-64: PHASED ARRAY TMJ COIL
Medical Advances, Inc.
LNH
Jan 25, 1995K944662FLEXART QD BODY COIL
Toshiba America Mri, Inc.
LNH
Jan 25, 1995K944469GENERAL PURPOSE FLEX COIL
Philips Medical Systems (Cleveland), Inc.
LNH
Jan 25, 1995K944331MODEL 528GE SERIES
Medical Advances, Inc.
LNH
Dec 30, 1994K9438002D,3D, TOF MR ANGIOGRAPHY
Hitachi Medical Systems America, Inc.
LNH
Dec 23, 1994K941582SUPERSENSOR MRI COIL
Superconductor Technologies, Inc.
LNH
Dec 22, 1994K944112MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
GE Medical Systems
LNH
Dec 15, 1994K943415MERIT (O.1T MR SYSTEM)
Philips Medical Systems (Cleveland), Inc.
LNH
Dec 9, 1994K943799VERSION 5 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
LNH
Dec 8, 1994K942874MODEL #300TO3500 SHOULDER COIL
Medic, Inc.
LNH
Dec 2, 1994K942875MODEL #900TO3500 HEAD/NECK COIL
Medic, Inc.
LNH

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