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
12766 Radiology devices
Cleared
May 14, 2004
DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D
IZI
System, X-ray, Angiographic
23d
Cleared
May 14, 2004
NEWTOM 3G QR-DVT 9000
OAS
X-ray, Tomography, Computed, Dental
14d
Cleared
May 14, 2004
MODIFICATION TO E-SCAN XQ MRI SYSTEM
MOS
Coil, Magnetic Resonance, Specialty
11d
Cleared
May 14, 2004
TORSO ARRAY COIL, MODEL 558GE-64
MOS
Coil, Magnetic Resonance, Specialty
8d
Cleared
May 13, 2004
COLOR LCD MONITOR, MODEL RADIFORCE R12
LLZ
System, Image Processing, Radiological
28d
Cleared
May 12, 2004
IMPAX OT3000 ORTHOPEDIC WORKSTATION
LLZ
System, Image Processing, Radiological
90d
Cleared
May 11, 2004
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
IYE
Accelerator, Linear, Medical
67d
Cleared
May 04, 2004
ARTOSCAN C
LNH
System, Nuclear Magnetic Resonance Imaging
29d
Cleared
Apr 28, 2004
COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
LLZ
System, Image Processing, Radiological
75d
Cleared
Apr 27, 2004
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
LLZ
System, Image Processing, Radiological
56d
Cleared
Apr 23, 2004
5M MEDICAL FLAT PANEL DISPLAY, ME511L
LLZ
System, Image Processing, Radiological
331d
Cleared
Apr 23, 2004
DICOM THEATER
LLZ
System, Image Processing, Radiological
206d
Cleared
Apr 23, 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
IZH
System, X-ray, Mammographic
18d
Cleared
Apr 21, 2004
HITACHI PRESTO
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Apr 20, 2004
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
HLI
Ophthalmoscope, Ac-powered
203d
Cleared
Apr 19, 2004
SENOGRAPHIC STEREO
IZH
System, X-ray, Mammographic
90d
Cleared
Apr 19, 2004
ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE
LLZ
System, Image Processing, Radiological
14d
Cleared
Apr 14, 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
85d
Cleared
Apr 14, 2004
TERATECH MODEL 10V5 SMART PROBE
ITX
Transducer, Ultrasonic, Diagnostic
13d
Cleared
Apr 12, 2004
MFCD 2320
LLZ
System, Image Processing, Radiological
80d
Cleared
Apr 07, 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
KPS
System, Tomography, Computed, Emission
72d
Cleared
Apr 07, 2004
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
EHD
Unit, X-ray, Extraoral With Timer
36d
Cleared
Apr 02, 2004
SOMATOM SENSATION 64 AND SENSATION CARDIAC
JAK
System, X-ray, Tomography, Computed
29d
Cleared
Apr 01, 2004
MODIFICATION TO ACCULEAF
IXI
Block, Beam-shaping, Radiation Therapy
30d
Cleared
Mar 31, 2004
ULTRASOUND IMAGING SYSTEM, MODEL 7300
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
23d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices