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
12643 Radiology devices
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
Cleared
May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
66d
Cleared
May 18, 2009
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
129d
Cleared
May 18, 2009
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
LLZ
System, Image Processing, Radiological
187d
Cleared
May 15, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
ITX
Transducer, Ultrasonic, Diagnostic
11d
Cleared
May 15, 2009
SYNGO US WORKPLACE
LLZ
System, Image Processing, Radiological
14d
Cleared
May 15, 2009
ZIEHM VISION RFD
OWB
Interventional Fluoroscopic X-ray System
168d
Cleared
May 14, 2009
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
KPS
System, Tomography, Computed, Emission
30d
Cleared
May 12, 2009
SEGMENT
LLZ
System, Image Processing, Radiological
47d
Cleared
May 08, 2009
NEUROPET
KPS
System, Tomography, Computed, Emission
8d
Cleared
May 08, 2009
SYNGO RT THERAPIST CONNECT
IYE
Accelerator, Linear, Medical
53d
Cleared
May 07, 2009
SPEQ ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
70d
Cleared
May 05, 2009
NIO 2MP (MDNG-2121)
LLZ
System, Image Processing, Radiological
13d
Cleared
May 05, 2009
GE VENUE 40, MODEL 5324338
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
13d
Cleared
May 05, 2009
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
LLZ
System, Image Processing, Radiological
14d
Cleared
May 05, 2009
PANTHER REALART, MODEL 4.7
MUJ
System, Planning, Radiation Therapy Treatment
161d
Cleared
May 04, 2009
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
MUJ
System, Planning, Radiation Therapy Treatment
98d
Cleared
May 01, 2009
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
MUJ
System, Planning, Radiation Therapy Treatment
11d
Cleared
May 01, 2009
TXRX 1.5T CP HEAD COIL
MOS
Coil, Magnetic Resonance, Specialty
14d
Cleared
May 01, 2009
OEC 9900 ELITE
OWB
Interventional Fluoroscopic X-ray System
221d
Cleared
Apr 30, 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
OAS
X-ray, Tomography, Computed, Dental
97d
Cleared
Apr 30, 2009
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
111d
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