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
12760 Radiology devices
Cleared
Jul 02, 2004
GE VIVID 7 BT04
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
23d
Cleared
Jul 02, 2004
SOURCELINK
KXK
Source, Brachytherapy, Radionuclide
21d
Cleared
Jun 30, 2004
PRECISION RXI ANALOG X-RAY SYSTEM
OWB
Interventional Fluoroscopic X-ray System
15d
Cleared
Jun 29, 2004
IMAGERAYI
MUH
System, X-ray, Extraoral Source, Digital
15d
Cleared
Jun 25, 2004
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
IYE
Accelerator, Linear, Medical
15d
Cleared
Jun 25, 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
11d
Cleared
Jun 24, 2004
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22
LLZ
System, Image Processing, Radiological
30d
Cleared
Jun 23, 2004
ACCUSOFT
MUJ
System, Planning, Radiation Therapy Treatment
120d
Cleared
Jun 22, 2004
VOLUME VIEWER PLUS
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Jun 22, 2004
GE DISCOVERY ST
KPS
System, Tomography, Computed, Emission
14d
Cleared
Jun 22, 2004
COMPACS, VERSION 1.0
LLZ
System, Image Processing, Radiological
8d
Cleared
Jun 21, 2004
STARPACS ORTHOPEDICS SYSTEM
LLZ
System, Image Processing, Radiological
14d
Cleared
Jun 18, 2004
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
JAQ
System, Applicator, Radionuclide, Remote-controlled
92d
Cleared
Jun 17, 2004
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
14d
Cleared
Jun 17, 2004
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
MOS
Coil, Magnetic Resonance, Specialty
13d
Cleared
Jun 17, 2004
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
JAK
System, X-ray, Tomography, Computed
9d
Cleared
Jun 16, 2004
HEXAPOD RT COUCHTOP
JAI
Couch, Radiation Therapy, Powered
15d
Cleared
Jun 15, 2004
GE DISCOVERY ST SYSTEM
KPS
System, Tomography, Computed, Emission
36d
Cleared
Jun 10, 2004
AXIOM ARTIS U
OWB
Interventional Fluoroscopic X-ray System
90d
Cleared
Jun 10, 2004
21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)
LLZ
System, Image Processing, Radiological
85d
Cleared
Jun 10, 2004
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
IYE
Accelerator, Linear, Medical
24d
Cleared
Jun 10, 2004
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
9d
Cleared
Jun 10, 2004
SSA-770A, APLIO VERSION 5.5
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
3d
Cleared
Jun 09, 2004
EG-3630UR
ITX
Transducer, Ultrasonic, Diagnostic
14d
Cleared
Jun 09, 2004
FG-36UX FIBER ULTRASOUND GASTROSCOPE
ITX
Transducer, Ultrasonic, Diagnostic
14d
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