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
12835 Radiology devices
Cleared
Jun 08, 1999
DOSE CALC, MODEL VS. 1.02
IYE
Accelerator, Linear, Medical
88d
Cleared
Jun 08, 1999
LINEAR SHOULDER COIL, MODEL 414GE-09
MOS
Coil, Magnetic Resonance, Specialty
68d
Cleared
Jun 08, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
JAK
System, X-ray, Tomography, Computed
36d
Cleared
Jun 08, 1999
IDS4 V3.2 IMAGE DISPLAY SYSTEM
LLZ
System, Image Processing, Radiological
26d
Cleared
Jun 03, 1999
SMARTSPOT 2000
LLZ
System, Image Processing, Radiological
28d
Cleared
Jun 03, 1999
SSA-370A/POWERVISION 6000
IYO
System, Imaging, Pulsed Echo, Ultrasonic
15d
Cleared
Jun 02, 1999
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,
ITX
Transducer, Ultrasonic, Diagnostic
51d
Cleared
Jun 01, 1999
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
IXC
Illuminator, Radiographic-film
46d
Cleared
May 28, 1999
DPD-12PCC
IYE
Accelerator, Linear, Medical
84d
Cleared
May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
JAQ
System, Applicator, Radionuclide, Remote-controlled
80d
Cleared
May 27, 1999
E-SCAN
LNH
System, Nuclear Magnetic Resonance Imaging
65d
Cleared
May 24, 1999
HITACHI VERSIFLEX
IZI
System, X-ray, Angiographic
42d
Cleared
May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
IWB
System, Radiation Therapy, Radionuclide
169d
Cleared
May 20, 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
KXK
Source, Brachytherapy, Radionuclide
119d
Cleared
May 20, 1999
LIFE IMAGING SYSTEMS, MODEL L3DI
IYO
System, Imaging, Pulsed Echo, Ultrasonic
87d
Cleared
May 20, 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
MOS
Coil, Magnetic Resonance, Specialty
51d
Cleared
May 20, 1999
AII-PRO 100 PLUS AND ALL-PRO 200
IXW
Processor, Radiographic-film, Automatic
24d
Cleared
May 19, 1999
OSTEOGRAM BONE DENSITOMETER
KGI
Densitometer, Bone
169d
Cleared
May 14, 1999
EXCELART
LNH
System, Nuclear Magnetic Resonance Imaging
78d
Cleared
May 13, 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
KXK
Source, Brachytherapy, Radionuclide
323d
Cleared
May 13, 1999
DMD DIGITAL X-RAY SYSTEM
MUH
System, X-ray, Extraoral Source, Digital
122d
Cleared
May 13, 1999
HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
KPS
System, Tomography, Computed, Emission
41d
Cleared
May 13, 1999
PHILIPS TOMOSCAN AV-NT
JAK
System, X-ray, Tomography, Computed
29d
Cleared
May 12, 1999
ROCS ULTRASEED
IYE
Accelerator, Linear, Medical
166d
Cleared
May 12, 1999
CALCIUM SCORING
JAK
System, X-ray, Tomography, Computed
90d
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