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
12771 Radiology devices
Cleared
Jun 20, 2003
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
KPS
System, Tomography, Computed, Emission
3d
Cleared
Jun 19, 2003
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
IZQ
Injector, Contrast Medium, Automatic
30d
Cleared
Jun 17, 2003
PHILIPS EASYDIAGNOST ELEVA
KPR
System, X-ray, Stationary
32d
Cleared
Jun 17, 2003
SKYLIGHT IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
15d
Cleared
Jun 11, 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
15d
Cleared
Jun 09, 2003
GE VIVID 7, MODEL FC0003XX
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
11d
Cleared
May 30, 2003
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
11d
Cleared
May 29, 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
LLZ
System, Image Processing, Radiological
79d
Cleared
May 29, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
MOS
Coil, Magnetic Resonance, Specialty
49d
Cleared
May 29, 2003
ALPHA 5000 WRIST COIL
MOS
Coil, Magnetic Resonance, Specialty
49d
Cleared
May 29, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
MOS
Coil, Magnetic Resonance, Specialty
45d
Cleared
May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
MOS
Coil, Magnetic Resonance, Specialty
36d
Cleared
May 22, 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
JAK
System, X-ray, Tomography, Computed
13d
Cleared
May 21, 2003
VARISEED 7.1
KXK
Source, Brachytherapy, Radionuclide
90d
Cleared
May 21, 2003
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
14d
Cleared
May 13, 2003
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
IZI
System, X-ray, Angiographic
15d
Cleared
May 13, 2003
ADVANTAGE WORKSTATION PASTING 1.1
LNH
System, Nuclear Magnetic Resonance Imaging
11d
Cleared
May 09, 2003
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
10d
Cleared
May 08, 2003
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
MOS
Coil, Magnetic Resonance, Specialty
35d
Cleared
May 08, 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
MOS
Coil, Magnetic Resonance, Specialty
31d
Cleared
May 06, 2003
CT COLONOGRAPHY
JAK
System, X-ray, Tomography, Computed
161d
Cleared
May 06, 2003
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
JAK
System, X-ray, Tomography, Computed
84d
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
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