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
12774 Radiology devices
Cleared
May 06, 2003
CARD EP
JAK
System, X-ray, Tomography, Computed
15d
Cleared
May 05, 2003
PRIMA III TOTALSENSE TORSO COIL
MOS
Coil, Magnetic Resonance, Specialty
90d
Cleared
May 02, 2003
20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
LLZ
System, Image Processing, Radiological
88d
Cleared
May 02, 2003
GE PROPELLER IMAGING OPTION FOR MRI
LNH
System, Nuclear Magnetic Resonance Imaging
14d
Cleared
Apr 25, 2003
FLAT PANEL DISPLAY, ME183L
LLZ
System, Image Processing, Radiological
88d
Cleared
Apr 25, 2003
MEDICAL FLAT PANEL DISPLAY, ME315L
LLZ
System, Image Processing, Radiological
88d
Cleared
Apr 25, 2003
FLAT PANEL DISPLAYS, CDL SERIES
LLZ
System, Image Processing, Radiological
88d
Cleared
Apr 17, 2003
GE LOGIQ 9 MODEL 2375600
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
23d
Cleared
Apr 16, 2003
A/T X-RAY 70
EHD
Unit, X-ray, Extraoral With Timer
114d
Cleared
Apr 10, 2003
GE 3.0T GENERAL PURPOSE FLEX COIL
MOS
Coil, Magnetic Resonance, Specialty
14d
Cleared
Apr 08, 2003
SYNGO COLONOGRAPHY SOFTWARE PACKAGE
LLZ
System, Image Processing, Radiological
11d
Cleared
Apr 07, 2003
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
12d
Cleared
Apr 03, 2003
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
JAQ
System, Applicator, Radionuclide, Remote-controlled
80d
Cleared
Mar 28, 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
8d
Cleared
Mar 26, 2003
DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
15d
Cleared
Mar 25, 2003
20.1 MONOCHROME LCD MONITOR, RADIFORCE G21
LLZ
System, Image Processing, Radiological
85d
Cleared
Mar 13, 2003
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
30d
Cleared
Mar 12, 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
KXK
Source, Brachytherapy, Radionuclide
2d
Cleared
Mar 10, 2003
STRYKERWARE SYSTEM
LLZ
System, Image Processing, Radiological
83d
Cleared
Mar 10, 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
JAK
System, X-ray, Tomography, Computed
28d
Cleared
Mar 06, 2003
INTERA FAMILY
LNH
System, Nuclear Magnetic Resonance Imaging
15d
Cleared
Mar 05, 2003
3.0T TORSO PHASED ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
14d
Cleared
Feb 24, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
MOS
Coil, Magnetic Resonance, Specialty
49d
Cleared
Feb 21, 2003
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
IZH
System, X-ray, Mammographic
253d
Cleared
Feb 21, 2003
LEO III TX/RX QUADRATURE KNEE COIL
MOS
Coil, Magnetic Resonance, Specialty
81d
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