System, Nuclear Magnetic Resonance Imaging

FDA product code LNH · 1071 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1000
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1988-09-02 – 2026-09-16

LNH 1990-03-08

MRT 50A SPINE SURFACE COIL

Applicant Toshiba America Mri, Inc.

K number K900286

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LNH 1990-02-02

MODEL: GYREX VERSION V

Applicant Elscint, Inc.

K number K896419

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LNH 1990-02-02

MODEL 8100; UPPER EXTREMITY COIL

Applicant Medical Advances, Inc.

K number K895629

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LNH 1990-01-23

MODEL 6000; VOLUME NECK COIL

Applicant Medical Advances, Inc.

K number K896789

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LNH 1990-01-12

VISTA MR 2055 HP SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K896508

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LNH 1990-01-12

MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC

Applicant Instrumentarium Imaging, Inc.

K number K896309

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LNH 1990-01-04

MODEL 5070; DUAL PLANAR PAIR

Applicant Medical Advances, Inc.

K number K894855

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LNH 1989-12-22

MODEL SPINE SURVEYOR-PLUS; CAT. #ACS-10A

Applicant Medical Advances, Inc.

K number K896336

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LNH 1989-12-21

GYROVIEW HR HIGH RESOLUTION WORKSTATION

Applicant Philips Medical Systems North America, Inc.

K number K896647

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LNH 1989-12-14

GYROSCAN T5 MOBILE

Applicant Philips Medical Systems, Inc.

K number K895869

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LNH 1989-11-30

MAGNETOM M, H, 42, 63, 42 SP AND 63 SP

Applicant Siemens Medical Solutions USA, Inc.

K number K895966

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LNH 1989-11-22

MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20

Applicant Summit World Trade Corp.

K number K894016

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LNH 1989-11-17

GE MR MAX SYSTEM

Applicant GE Medical Systems

K number K895794

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LNH 1989-11-15

1989 SOFTWARE REVISION TO THE BMT-1100

Applicant Bruker Medical Imaging, Inc.

K number K894714

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LNH 1989-11-06

SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM

Applicant Shimadzu Medical Systems

K number K893744

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LNH 1989-10-30

VISTA MR 2055 HP SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K895151

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LNH 1989-10-27

MODEL 2031 TMJ SURFACE COIL

Applicant Medical Advances, Inc.

K number K895131

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LNH 1989-10-27

MT/S SOFTWARE RELEASE 5.0.

Applicant Diasonics, Inc.

K number K893518

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LNH 1989-10-03

ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42

Applicant Siemens Medical Solutions USA, Inc.

K number K895221

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LNH 1989-09-12

MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM

Applicant Resonex, Inc.

K number K894974

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LNH 1989-09-07

ACCESS TM

Applicant Diasonics, Inc.

K number K894290

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LNH 1989-08-11

GE SIGNA ADVANTAGE

Applicant GE Medical Systems

K number K893509

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LNH 1989-08-09

MRT-50A MOBILE

Applicant Toshiba Medical Systems

K number K893750

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LNH 1989-08-02

SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM

Applicant Siemens Medical Solutions USA, Inc.

K number K893640

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LNH 1989-07-20

VISION INTEGRATED PERFORMANCE OPTION

Applicant Siemens Medical Solutions USA, Inc.

K number K893689

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LNH 1989-07-14

VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES

Applicant Philips Medical Systems (Cleveland), Inc.

K number K893739

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LNH 1989-07-14

VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES

Applicant Philips Medical Systems (Cleveland), Inc.

K number K893675

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LNH 1989-06-23

ACCESS TM

Applicant Diasonics, Inc.

K number K893881

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LNH 1989-06-23

VISTA MR 2055 HP SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K893619

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LNH 1989-06-23

MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED

Applicant Bruker Medical Imaging, Inc.

K number K891760

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LNH 1989-06-23

MAGNAVIEW MOBILE MRI VERSION 110 FHM

Applicant Instrumentarium Imaging, Inc.

K number K891543

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LNH 1989-06-23

HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Applicant Health Images, Inc.

K number K890092

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LNH 1989-06-15

MAGNISCAN 5000 MR SYSTEM

Applicant General Electric Co.

K number K891769

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LNH 1989-06-01

VERSION 4.2 APPLICATION SOFTWARE

Applicant Resonex, Inc.

K number K892959

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LNH 1989-05-11

GE SHOULDER SURFACE COIL, CAT. #M1085AN

Applicant General Electric Co.

K number K892235

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LNH 1989-05-11

MODEL 2030; 3 TMJ SURFACE COIL

Applicant Medical Advances, Inc.

K number K891598

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LNH 1989-05-11

MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.

Applicant Diasonics, Inc.

K number K891541

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LNH 1989-05-01

MODEL 4041; 4 ANGLED PAIR CRC SURFACE COIL

Applicant Medical Advances, Inc.

K number K890855

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LNH 1989-04-28

GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Applicant Philips Medical Systems North America, Inc.

K number K890789

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LNH 1989-04-14

MODEL 3031; CERVICAL SPINE SURFACE COIL

Applicant Medical Advances, Inc.

K number K890666

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LNH 1989-04-03

MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES

Applicant Siemens Medical Solutions USA, Inc.

K number K890815

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LNH 1989-03-14

MEDRAD SCPD 1000

Applicant Medrad, Inc.

K number K890394

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LNH 1989-03-14

VISTA MR 2055 HP SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K885047

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LNH 1989-02-17

RMI SHORT DISTANCE ALIGNMENT DEVICE

Applicant Radiation Measurements, Inc.

K number K885223

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LNH 1989-02-02

ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY

Applicant Diasonics, Inc.

K number K884816

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LNH 1989-01-24

MAGNETOM 42 SP AND MAGNETOM 63 SP

Applicant Siemens Medical Solutions USA, Inc.

K number K883898

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LNH 1989-01-17

MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL

Applicant Siemens Medical Solutions USA, Inc.

K number K884484

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LNH 1988-12-21

MT/S (SOFTWARE RELEASE 3.1)

Applicant Diasonics, Inc.

K number K884607

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LNH 1988-12-05

TEMPOROMANDIBULAR JOINT COIL (TMJ)

Applicant Diasonics, Inc.

K number K884743

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LNH 1988-12-05

MT/S (SPINE TRANSMIT COIL)

Applicant Diasonics, Inc.

K number K884606

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LNH 1988-11-30

MT/S CARLSON SPINE COIL, PART # 100-50082500-01

Applicant Diasonics, Inc.

K number K884604

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LNH 1988-11-30

SHOULDER TRANSMIT AND RECEIVE COILS

Applicant Diasonics, Inc.

K number K884603

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LNH 1988-11-30

GE MR MAX SYSTEM

Applicant General Electric Co.

K number K883547

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LNH 1988-11-28

POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM

Applicant General Electric Co.

K number K884369

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LNH 1988-11-23

MAGNETOM (M, H, 42, 63) SEQUENCES

Applicant Siemens Medical Solutions USA, Inc.

K number K884062

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LNH 1988-11-21

VISTA MR 2055 HP SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K883994

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LNH 1988-11-21

CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL

Applicant Siemens Medical Solutions USA, Inc.

K number K883872

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LNH 1988-11-14

TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM

Applicant Toshiba Medical Systems

K number K883756

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LNH 1988-11-10

INSTRUMENTARIUM ULF MR IMAGING SYSTEM

Applicant Instrumentarium Corp.

K number K883621

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LNH 1988-10-31

B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER

Applicant Fonar Corp.

K number K883699

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LNH 1988-10-19

INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H

Applicant Instrumentarium Corp.

K number K883649

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LNH 1988-10-19

BETA 3000M MOBILE NMR IMAGING SYSTEM

Applicant Fonar Corp.

K number K883648

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LNH 1988-10-19

FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)

Applicant Philips Medical Systems (Cleveland), Inc.

K number K883519

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LNH 1988-10-19

VISTA MR 2055 HP SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K883482

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LNH 1988-10-13

VFQ HEAD COIL

Applicant Resonex, Inc.

K number K883737

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LNH 1988-10-07

0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST

Applicant Philips Medical Systems (Cleveland), Inc.

K number K883520

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LNH 1988-10-07

DIASONICS MT/P IMAGING SYSTEM

Applicant Diasonics, Inc.

K number K883516

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LNH 1988-09-22

VISTA MR 2055 HP SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K883378

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LNH 1988-09-16

INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110

Applicant Instrumentarium Corp.

K number K883650

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LNH 1988-09-14

INSTRUMENTARIUM ULF MR IMAGING SYSTEM

Applicant Instrumentarium Corp.

K number K883622

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LNH 1988-09-02

C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS

Applicant Philips Medical Systems (Cleveland), Inc.

K number K883521

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