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
12652 Radiology devices
Cleared
Oct 21, 2008
SHOWCASE
LLZ
System, Image Processing, Radiological
84d
Cleared
Oct 17, 2008
P3T ABDOMEN
JAK
System, X-ray, Tomography, Computed
52d
Cleared
Oct 17, 2008
GE XTREME INJECTOR OPTION
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Oct 17, 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
MOS
Coil, Magnetic Resonance, Specialty
8d
Cleared
Oct 16, 2008
VB IMAGE VIEWER
JAK
System, X-ray, Tomography, Computed
227d
Cleared
Oct 16, 2008
OSDX HIP BMD SYSTEM
KGI
Densitometer, Bone
57d
Cleared
Oct 15, 2008
XR-EXPRESS
LLZ
System, Image Processing, Radiological
62d
Cleared
Oct 15, 2008
HRB-127-32 HIGH RESOLUTION BRAIN COIL
MOS
Coil, Magnetic Resonance, Specialty
15d
Cleared
Oct 14, 2008
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
IYO
System, Imaging, Pulsed Echo, Ultrasonic
41d
Cleared
Oct 14, 2008
4D VIEWER RADIOLOGY, MODEL USWP-100A
LLZ
System, Image Processing, Radiological
29d
Cleared
Oct 10, 2008
SOMATOM FLASH DS
JAK
System, X-ray, Tomography, Computed
65d
Cleared
Oct 10, 2008
PAX-500
OAS
X-ray, Tomography, Computed, Dental
56d
Cleared
Oct 10, 2008
CENTERING INTRALUMINAL APPLICATOR
JAQ
System, Applicator, Radionuclide, Remote-controlled
28d
Cleared
Oct 10, 2008
INFX-8000H, INFINIX-I
JAA
System, X-ray, Fluoroscopic, Image-intensified
14d
Cleared
Oct 08, 2008
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
62d
Cleared
Oct 08, 2008
ZONARE ULTRA ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
55d
Cleared
Oct 08, 2008
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
16d
Cleared
Oct 08, 2008
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
13d
Cleared
Oct 07, 2008
STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
IYE
Accelerator, Linear, Medical
92d
Cleared
Oct 06, 2008
COLOR LCD MONITOR
LLZ
System, Image Processing, Radiological
24d
Cleared
Oct 01, 2008
MAGNETOM C!
LNH
System, Nuclear Magnetic Resonance Imaging
48d
Cleared
Oct 01, 2008
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
LLZ
System, Image Processing, Radiological
33d
Cleared
Sep 30, 2008
CIVASTRING PD-103
KXK
Source, Brachytherapy, Radionuclide
61d
Cleared
Sep 30, 2008
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
18d
Cleared
Sep 26, 2008
UNISYN IMAGE FUSION, VERSION 1.0
LLZ
System, Image Processing, Radiological
74d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices