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
12636 Radiology devices
Cleared
Nov 20, 2009
ACU007S
KXK
Source, Brachytherapy, Radionuclide
94d
Cleared
Nov 17, 2009
VARIAN INTERSTITIAL TITANIUM NEEDLES
JAQ
System, Applicator, Radionuclide, Remote-controlled
27d
Cleared
Nov 17, 2009
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
112d
Cleared
Nov 13, 2009
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER
IYO
System, Imaging, Pulsed Echo, Ultrasonic
79d
Cleared
Nov 12, 2009
VIZTEK WL
KPR
System, X-ray, Stationary
149d
Cleared
Nov 10, 2009
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
KNG
Monitor, Ultrasonic, Fetal
43d
Cleared
Nov 10, 2009
COLOR LCD MONITOR, MODEL RADIFORCE MX241W
LLZ
System, Image Processing, Radiological
63d
Cleared
Nov 06, 2009
DX-D IMAGING PACKAGE
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
67d
Cleared
Nov 06, 2009
SHIMADZU COLLIMATOR R-30H
IZW
Collimator, Automatic, Radiographic
248d
Cleared
Oct 30, 2009
INTEGRATED REGISTRATION
LLZ
System, Image Processing, Radiological
15d
Cleared
Oct 30, 2009
DIRECT DIGITIZER, REGIUS MODEL 210
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
57d
Cleared
Oct 30, 2009
MITS DICOM GATEWAY AND IMAGE MANAGER
LLZ
System, Image Processing, Radiological
70d
Cleared
Oct 30, 2009
DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX
MUH
System, X-ray, Extraoral Source, Digital
72d
Cleared
Oct 16, 2009
CYPHER DICOM PRINT SOLUTION
LMC
Camera, Multi Format, Radiological
80d
Cleared
Oct 15, 2009
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
43d
Cleared
Oct 09, 2009
APLIO MX SSA-780A, VERSION 1.0
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Oct 09, 2009
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
JAK
System, X-ray, Tomography, Computed
31d
Cleared
Oct 09, 2009
VOYAGER COMPACT IMAGING SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
80d
Cleared
Oct 09, 2009
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
EHD
Unit, X-ray, Extraoral With Timer
87d
Cleared
Oct 09, 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
JAK
System, X-ray, Tomography, Computed
185d
Cleared
Oct 08, 2009
MICROSELECTRON HDR V2, MODEL 105.999
JAQ
System, Applicator, Radionuclide, Remote-controlled
27d
Cleared
Oct 08, 2009
MODIFICATION TO FMRI HARDWARE SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
72d
Cleared
Oct 08, 2009
PMD VIEWER
LLZ
System, Image Processing, Radiological
78d
Cleared
Oct 07, 2009
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
OWB
Interventional Fluoroscopic X-ray System
99d
Cleared
Oct 02, 2009
MODEL SENTINELLA 102
IYX
Camera, Scintillation (gamma)
52d
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