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
12706 Radiology devices
Cleared
May 23, 2007
5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC
LLZ
System, Image Processing, Radiological
205d
Cleared
May 22, 2007
AOS MARKER SEEDS
KXK
Source, Brachytherapy, Radionuclide
244d
Cleared
May 22, 2007
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
JAQ
System, Applicator, Radionuclide, Remote-controlled
244d
Cleared
May 22, 2007
VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
LLZ
System, Image Processing, Radiological
57d
Cleared
May 22, 2007
FUJI IP CASSETTE TYPE PC
IYE
Accelerator, Linear, Medical
50d
Cleared
May 22, 2007
RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
LLZ
System, Image Processing, Radiological
36d
Cleared
May 22, 2007
.DECIMAL RANGE COMPENSATOR
IXI
Block, Beam-shaping, Radiation Therapy
35d
Cleared
May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
LNH
System, Nuclear Magnetic Resonance Imaging
33d
Cleared
May 22, 2007
SYNGO IMAGING (VERSION V30)
LLZ
System, Image Processing, Radiological
32d
Cleared
May 22, 2007
NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
13d
Cleared
May 22, 2007
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
IYO
System, Imaging, Pulsed Echo, Ultrasonic
12d
Cleared
May 18, 2007
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
OWB
Interventional Fluoroscopic X-ray System
52d
Cleared
May 18, 2007
.DECIMAL APERTURE
IXI
Block, Beam-shaping, Radiation Therapy
31d
Cleared
May 18, 2007
SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
IYO
System, Imaging, Pulsed Echo, Ultrasonic
17d
Cleared
May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
JAQ
System, Applicator, Radionuclide, Remote-controlled
15d
Cleared
May 17, 2007
BLADDERSCAN BVI 9400 ULTRASOUND
IYO
System, Imaging, Pulsed Echo, Ultrasonic
15d
Cleared
May 16, 2007
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
34d
Cleared
May 15, 2007
LMS-LUNG/TRACK
LLZ
System, Image Processing, Radiological
47d
Cleared
May 14, 2007
MYRIAN
LLZ
System, Image Processing, Radiological
35d
Cleared
May 14, 2007
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
KPS
System, Tomography, Computed, Emission
28d
Cleared
May 10, 2007
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
IZL
System, X-ray, Mobile
30d
Cleared
May 10, 2007
SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
IZI
System, X-ray, Angiographic
28d
Cleared
May 10, 2007
SUPERSTAR 0.35T MRI SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
15d
Cleared
May 09, 2007
SYNEPIX 4600 DETECTOR
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
44d
Cleared
May 08, 2007
INTERWORKS
LLZ
System, Image Processing, Radiological
50d
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