FDA 510(k) Radiology Devices
FDA 510(k) Radiology Devices - Regulatory Overview
FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.
Key modalities covered:
- X-ray and fluoroscopy - digital radiography, fluoroscopy systems and C-arms
- Computed tomography (CT) - whole-body and dedicated CT scanners
- Magnetic resonance imaging (MRI) - 1.5T, 3T and extremity MRI systems
- Ultrasound imaging - diagnostic, point-of-care and intravascular ultrasound
- Radiation therapy - linear accelerators, brachytherapy and treatment planning
- Nuclear medicine - PET, SPECT and gamma camera systems
15620
Total
15601
Cleared
148d
Avg (2y)
1976
Since
12789 Radiology devices
Cleared
Aug 03, 2001
IN SPACE 3D
JAK
System, X-ray, Tomography, Computed
84d
Cleared
Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
21d
Cleared
Jul 31, 2001
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
IYE
Accelerator, Linear, Medical
285d
Cleared
Jul 31, 2001
QCU ANALYTICAL SOFTWARE PACKAGE
LLZ
System, Image Processing, Radiological
69d
Cleared
Jul 31, 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
LLZ
System, Image Processing, Radiological
26d
Cleared
Jul 26, 2001
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
13d
Cleared
Jul 20, 2001
NORTHEAST PROTON THERAPY CENTER
LHN
System, Radiation Therapy, Charged-particle, Medical
1032d
Cleared
Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
LNH
System, Nuclear Magnetic Resonance Imaging
80d
Cleared
Jul 12, 2001
VARISEED 7.0
MUJ
System, Planning, Radiation Therapy Treatment
14d
Cleared
Jul 12, 2001
PROTON THERAPY SYSTEM
LHN
System, Radiation Therapy, Charged-particle, Medical
1046d
Cleared
Jul 03, 2001
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
JAK
System, X-ray, Tomography, Computed
81d
Cleared
Jun 29, 2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
EHD
Unit, X-ray, Extraoral With Timer
35d
Cleared
Jun 27, 2001
CYPRESS SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
90d
Cleared
Jun 26, 2001
SYNGO MULTIMODALITY WORKSTATION
LLZ
System, Image Processing, Radiological
89d
Cleared
Jun 20, 2001
ZIEHM VISION
OWB
Interventional Fluoroscopic X-ray System
51d
Cleared
Jun 15, 2001
MX8000 V5.0 CT SYSTEM
JAK
System, X-ray, Tomography, Computed
88d
Cleared
Jun 15, 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
KPS
System, Tomography, Computed, Emission
25d
Cleared
Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
JAA
System, X-ray, Fluoroscopic, Image-intensified
14d
Cleared
May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
LNH
System, Nuclear Magnetic Resonance Imaging
77d
Cleared
May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
MOS
Coil, Magnetic Resonance, Specialty
62d
Cleared
May 25, 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
MOS
Coil, Magnetic Resonance, Specialty
193d
Cleared
May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
12d
Cleared
May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
30d
Cleared
May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
MOS
Coil, Magnetic Resonance, Specialty
65d
Cleared
May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
JAK
System, X-ray, Tomography, Computed
30d
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