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
Dec 23, 2002
IMAGETILE
LLZ
System, Image Processing, Radiological
77d
Cleared
Dec 23, 2002
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
LLZ
System, Image Processing, Radiological
77d
Cleared
Dec 23, 2002
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
LLZ
System, Image Processing, Radiological
77d
Cleared
Dec 23, 2002
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
LLZ
System, Image Processing, Radiological
32d
Cleared
Dec 19, 2002
PHILIPS EASYVISION WORKSTATION RELEASE 6
LLZ
System, Image Processing, Radiological
90d
Cleared
Dec 19, 2002
ECHO SOUNDER, ES-102EX
KNG
Monitor, Ultrasonic, Fetal
90d
Cleared
Dec 18, 2002
ALOKA SSD-3500 ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Dec 16, 2002
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
MOS
Coil, Magnetic Resonance, Specialty
90d
Cleared
Dec 13, 2002
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
LLZ
System, Image Processing, Radiological
114d
Cleared
Dec 12, 2002
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Dec 11, 2002
GE PHOTON ENERGY RECOVERY (PER) OPTION
KPS
System, Tomography, Computed, Emission
15d
Cleared
Nov 26, 2002
INNOVA 4100
OWB
Interventional Fluoroscopic X-ray System
64d
Cleared
Nov 25, 2002
ECAT PET/CT
KPS
System, Tomography, Computed, Emission
13d
Cleared
Nov 22, 2002
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
JAA
System, X-ray, Fluoroscopic, Image-intensified
80d
Cleared
Nov 22, 2002
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
KPS
System, Tomography, Computed, Emission
64d
Cleared
Nov 22, 2002
SOMATOM EMOTION 6 CT SYSTEMS
JAK
System, X-ray, Tomography, Computed
21d
Cleared
Nov 22, 2002
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
14d
Cleared
Nov 22, 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Nov 22, 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
LLZ
System, Image Processing, Radiological
10d
Cleared
Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
ITX
Transducer, Ultrasonic, Diagnostic
85d
Cleared
Nov 20, 2002
6 CHANNEL BODY COIL
MOS
Coil, Magnetic Resonance, Specialty
27d
Cleared
Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Nov 18, 2002
GORE 3.0T TORSO ARRAY
MOS
Coil, Magnetic Resonance, Specialty
17d
Cleared
Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
KGI
Densitometer, Bone
30d
Cleared
Nov 08, 2002
ECAT LSO PET/CT 16
KPS
System, Tomography, Computed, Emission
18d
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