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
12743 Radiology devices
Cleared
May 26, 2005
ZIEHM QUANTUM
OWB
Interventional Fluoroscopic X-ray System
30d
Cleared
May 26, 2005
RAYCELL X-RAY BLOOD IRRADIATOR
MOT
Irradiator, Blood To Prevent Graft Versus Host Disease
30d
Cleared
May 26, 2005
E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY
LLZ
System, Image Processing, Radiological
15d
Cleared
May 23, 2005
INTEGRA IMMOBILIZATION SYSTEM
IYE
Accelerator, Linear, Medical
46d
Cleared
May 23, 2005
GE VIEWPOINT
LLZ
System, Image Processing, Radiological
39d
Cleared
May 23, 2005
INTRABEAM SYSTEM
JAD
System, Therapeutic, X-ray
27d
Cleared
May 23, 2005
GEMINI GXL
KPS
System, Tomography, Computed, Emission
17d
Cleared
May 20, 2005
WIMRT MODULE FOR ARTP PLANNING SYSTEM
MUJ
System, Planning, Radiation Therapy Treatment
302d
Cleared
May 20, 2005
ATLANTIS PV
DQO
Catheter, Intravascular, Diagnostic
64d
Cleared
May 20, 2005
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
MOT
Irradiator, Blood To Prevent Graft Versus Host Disease
32d
Cleared
May 13, 2005
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
JAA
System, X-ray, Fluoroscopic, Image-intensified
21d
Cleared
May 13, 2005
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
9d
Cleared
May 12, 2005
ESSENPACS
LLZ
System, Image Processing, Radiological
15d
Cleared
May 05, 2005
ACCUCHANGER
IYE
Accelerator, Linear, Medical
146d
Cleared
May 05, 2005
IMORGON ULTRASOUND PACS SOLUTIONS
LLZ
System, Image Processing, Radiological
45d
Cleared
May 05, 2005
O-ARM IMAGING SYSTEM
OXO
Image-intensified Fluoroscopic X-ray System, Mobile
15d
Cleared
May 05, 2005
DOPPLER-BOX
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
7d
Cleared
Apr 27, 2005
CENTRION 500 C-ARM SYSTEM
JAA
System, X-ray, Fluoroscopic, Image-intensified
22d
Cleared
Apr 27, 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
8d
Cleared
Apr 26, 2005
20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB
LLZ
System, Image Processing, Radiological
47d
Cleared
Apr 26, 2005
XACT.CARDIAC & XPRESS.CARDIAC
KPS
System, Tomography, Computed, Emission
26d
Cleared
Apr 22, 2005
21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB
LLZ
System, Image Processing, Radiological
43d
Cleared
Apr 21, 2005
21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB
LLZ
System, Image Processing, Radiological
42d
Cleared
Apr 21, 2005
QBRAIN
LLZ
System, Image Processing, Radiological
34d
Cleared
Apr 21, 2005
KAVO ERGOCOM/ERGOCAM
LLZ
System, Image Processing, Radiological
30d
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