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
12617 Radiology devices
Cleared
Jul 13, 2011
CARDIAC SCANNER AND PROCESSING SYSTEM
KPS
System, Tomography, Computed, Emission
141d
Cleared
Jul 08, 2011
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
46d
Cleared
Jul 05, 2011
SV DBS VRAIN ARRAY
MOS
Coil, Magnetic Resonance, Specialty
62d
Cleared
Jul 01, 2011
ENDOSCOUT TRACKING SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
60d
Cleared
Jul 01, 2011
SIMPLANT 2011
LLZ
System, Image Processing, Radiological
149d
Cleared
Jun 30, 2011
ACUSON
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Jun 30, 2011
CLIO/CLIOSOFT
LLZ
System, Image Processing, Radiological
92d
Cleared
Jun 30, 2011
SCANORA 3D
OAS
X-ray, Tomography, Computed, Dental
97d
Cleared
Jun 28, 2011
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
47d
Cleared
Jun 28, 2011
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
ITX
Transducer, Ultrasonic, Diagnostic
102d
Cleared
Jun 24, 2011
IMPAX VOLUME VIEWING
LLZ
System, Image Processing, Radiological
11d
Cleared
Jun 24, 2011
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
23d
Cleared
Jun 24, 2011
DISPOSABLE THYROID COLLAR
KPY
Shield, Protective, Personnel
85d
Cleared
Jun 24, 2011
MONACO RTP SYSTEM
MUJ
System, Planning, Radiation Therapy Treatment
100d
Cleared
Jun 22, 2011
SURGIVISION INC. CLEARPOINT SYSTEM
ORR
Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
65d
Cleared
Jun 21, 2011
CT-GUIDE NEEDLE GUIDANCE SYSTEM
JAK
System, X-ray, Tomography, Computed
90d
Cleared
Jun 21, 2011
QLAB 8.1 QUANTIFICATION SOFTWARE
LLZ
System, Image Processing, Radiological
127d
Cleared
Jun 16, 2011
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
IZL
System, X-ray, Mobile
204d
Cleared
Jun 15, 2011
MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY
LLZ
System, Image Processing, Radiological
44d
Cleared
Jun 10, 2011
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
OWB
Interventional Fluoroscopic X-ray System
29d
Cleared
Jun 08, 2011
10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
LLZ
System, Image Processing, Radiological
169d
Cleared
Jun 08, 2011
BIOGRAPH MMR
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
198d
Cleared
Jun 03, 2011
DISCOVERY NM 630
KPS
System, Tomography, Computed, Emission
10d
Cleared
Jun 03, 2011
LUMINOS AGILE
JAA
System, X-ray, Fluoroscopic, Image-intensified
28d
Cleared
Jun 02, 2011
MYLABGOLD
IYO
System, Imaging, Pulsed Echo, Ultrasonic
83d
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