Medical Device Manufacturer · US , Sunnyvale , CA

Resonex, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1988
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Resonex, Inc. Radiology
21 devices
1-21 of 21
Cleared Mar 21, 1994
FAST SPIN ECHO (FSE)
K935369 · LNH
Radiology · 137d
Cleared Mar 16, 1994
NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM
K935570 · LNH
Radiology · 118d
Cleared Nov 02, 1993
ECG GATING UNIT
K931392 · LNH
Radiology · 228d
Cleared Jan 12, 1993
3DTOF MRA
K923870 · LNH
Radiology · 162d
Cleared Nov 23, 1992
KINEMATIC MRI MOVIEMAKER
K924154 · LNH
Radiology · 97d
Cleared Oct 30, 1992
3D IMAGING
K923823 · LNH
Radiology · 92d
Cleared Sep 04, 1992
MAGNETIZATION TRANSFER CONTRAST
K922677 · LNH
Radiology · 92d
Cleared Jun 22, 1992
COILS FOR RX4000 & RX5000 MRI SYSTEMS
K920254 · LNH
Radiology · 153d
Cleared May 28, 1992
BO POWER SUPPLY
K921046 · LNH
Radiology · 85d
Cleared May 22, 1992
PRESATURATION
K920835 · LNH
Radiology · 88d
Cleared Mar 16, 1992
16 BIT A/D
K915754 · LNH
Radiology · 84d
Cleared Dec 04, 1991
2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)
K914114 · LNH
Radiology · 82d
Cleared Nov 01, 1991
40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE
K913325 · LNH
Radiology · 99d
Cleared Jul 03, 1991
COIL FIELD EXTENDER
K911800 · LNH
Radiology · 71d
Cleared Jun 20, 1991
RX-5000 MRI SYSTEM
K911892 · LNH
Radiology · 55d
Cleared Apr 08, 1991
10 ADJUSTABLE BELT COIL
K910269 · LNH
Radiology · 76d
Cleared Jul 19, 1990
BILATERAL TMJ COIL
K902630 · LNH
Radiology · 35d
Cleared May 07, 1990
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
K901602 · LNH
Radiology · 31d
Cleared Sep 12, 1989
MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM
K894974 · LNH
Radiology · 36d
Cleared Jun 01, 1989
VERSION 4.2 APPLICATION SOFTWARE
K892959 · LNH
Radiology · 38d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737 · LNH
Radiology · 42d
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