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
12639 Radiology devices
Cleared
Jun 15, 2009
DIGITAL RADIOGRAPHY CXDI-60C
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
19d
Cleared
Jun 15, 2009
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
JAK
System, X-ray, Tomography, Computed
60d
Cleared
Jun 15, 2009
ONCENTRA SIMULATION 2.3
KPQ
System, Simulation, Radiation Therapy
90d
Cleared
Jun 08, 2009
MODIFICATION TO NORDICICE SOFTWARE
LLZ
System, Image Processing, Radiological
98d
Cleared
Jun 05, 2009
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
LLZ
System, Image Processing, Radiological
16d
Cleared
Jun 04, 2009
R2 DIGITALNOW HD(DIGITALNOW HD)
LLZ
System, Image Processing, Radiological
27d
Cleared
Jun 02, 2009
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
OAS
X-ray, Tomography, Computed, Dental
154d
Cleared
Jun 02, 2009
I-MAX TOUCH
MUH
System, X-ray, Extraoral Source, Digital
231d
Cleared
May 29, 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
15d
Cleared
May 29, 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
15d
Cleared
May 28, 2009
DEXIS SENSOR
MUH
System, X-ray, Extraoral Source, Digital
94d
Cleared
May 27, 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
JAK
System, X-ray, Tomography, Computed
34d
Cleared
May 27, 2009
FLEXIPLAN 3D AND 3D+
MUJ
System, Planning, Radiation Therapy Treatment
37d
Cleared
May 27, 2009
RADCALC SOFTWARE, VERSION 6.0
MUJ
System, Planning, Radiation Therapy Treatment
89d
Cleared
May 27, 2009
RIC CONFORMAL SOURCE, MODEL 100
ONL
Conformal Brachytherapy Source
107d
Cleared
May 26, 2009
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
IYO
System, Imaging, Pulsed Echo, Ultrasonic
15d
Cleared
May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
LMC
Camera, Multi Format, Radiological
88d
Cleared
May 22, 2009
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
LLZ
System, Image Processing, Radiological
88d
Cleared
May 22, 2009
CAAS MR FLOW 1.0
LLZ
System, Image Processing, Radiological
120d
Cleared
May 20, 2009
SYNGO TRUED
LLZ
System, Image Processing, Radiological
9d
Cleared
May 19, 2009
EG-3870UTK
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
112d
Cleared
May 19, 2009
EG-3670URK
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
112d
Cleared
May 18, 2009
UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,
JAQ
System, Applicator, Radionuclide, Remote-controlled
27d
Cleared
May 18, 2009
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
39d
Cleared
May 18, 2009
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
EHD
Unit, X-ray, Extraoral With Timer
59d
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