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
12719 Radiology devices
Cleared
Nov 02, 2006
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
20d
Cleared
Nov 01, 2006
ECLIPSE TCD NEUROVASCULAR WORKSTATION
GWF
Stimulator, Electrical, Evoked Response
142d
Cleared
Oct 31, 2006
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
IZL
System, X-ray, Mobile
68d
Cleared
Oct 31, 2006
IMT.LAB SOFTWARE
LLZ
System, Image Processing, Radiological
60d
Cleared
Oct 31, 2006
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
LLZ
System, Image Processing, Radiological
47d
Cleared
Oct 30, 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
MUJ
System, Planning, Radiation Therapy Treatment
31d
Cleared
Oct 27, 2006
VISTADENT OC - VERSION 4
LLZ
System, Image Processing, Radiological
213d
Cleared
Oct 27, 2006
GYNESONICS EC6 TRANSDUCER
ITX
Transducer, Ultrasonic, Diagnostic
184d
Cleared
Oct 27, 2006
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
73d
Cleared
Oct 27, 2006
AMICAS VISION SERIES PACS, MODEL 4.3
LLZ
System, Image Processing, Radiological
64d
Cleared
Oct 27, 2006
VISAGE PACS/CS, RELEASE VERSION 4.1
LLZ
System, Image Processing, Radiological
63d
Cleared
Oct 27, 2006
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
LNH
System, Nuclear Magnetic Resonance Imaging
32d
Cleared
Oct 27, 2006
3DNET SUITE
LLZ
System, Image Processing, Radiological
16d
Cleared
Oct 20, 2006
D-SPECT CARDIAC SCANNER SYSTEM
KPS
System, Tomography, Computed, Emission
59d
Cleared
Oct 20, 2006
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
OWB
Interventional Fluoroscopic X-ray System
44d
Cleared
Oct 20, 2006
BIOLUCENT APPLICATOR KIT
JAQ
System, Applicator, Radionuclide, Remote-controlled
30d
Cleared
Oct 19, 2006
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
LHQ
System, Telethermographic (adjunctive Use)
15d
Cleared
Oct 18, 2006
CENTARISONE RIS/PACS
LLZ
System, Image Processing, Radiological
15d
Cleared
Oct 18, 2006
SYNGO LUNG CAD
OEB
Lung Computed Tomography System, Computer-aided Detection
6d
Cleared
Oct 13, 2006
CR 85-X
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
29d
Cleared
Oct 13, 2006
CTL-63 AND CTL-128 SPINE ARRAY COILS
MOS
Coil, Magnetic Resonance, Specialty
28d
Cleared
Oct 06, 2006
5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
LLZ
System, Image Processing, Radiological
78d
Cleared
Oct 06, 2006
ORTHOXP
KPR
System, X-ray, Stationary
30d
Cleared
Oct 05, 2006
ACCUSOFT, ACCUSOFT XL
MUJ
System, Planning, Radiation Therapy Treatment
79d
Cleared
Oct 05, 2006
SYNGO DUAL ENERGY
JAK
System, X-ray, Tomography, Computed
55d
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