Medical Device Manufacturer · US , Sunnyvale , CA

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

21 submissions · 21 cleared · Since 1988

Recent clearances: FAST SPIN ECHO (FSE), NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM, ECG GATING UNIT

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Resonex, Inc. Radiology ✕

21 devices

1-12 of 21

Cleared Mar 21, 1994

FAST SPIN ECHO (FSE)

Radiology · 137d

Cleared Mar 16, 1994

NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM

Radiology · 118d

Cleared Nov 02, 1993

ECG GATING UNIT

Radiology · 228d

Cleared Jan 12, 1993

Radiology · 162d

Cleared Nov 23, 1992

KINEMATIC MRI MOVIEMAKER

Radiology · 97d

Cleared Oct 30, 1992

Radiology · 92d

Cleared Sep 04, 1992

MAGNETIZATION TRANSFER CONTRAST

Radiology · 92d

Cleared Jun 22, 1992

COILS FOR RX4000 & RX5000 MRI SYSTEMS

Radiology · 153d

Cleared May 28, 1992

BO POWER SUPPLY

Radiology · 85d

Cleared May 22, 1992

Radiology · 88d

Cleared Mar 16, 1992

Radiology · 84d

Cleared Dec 04, 1991

2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)

Radiology · 82d