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
12554 Radiology devices
Cleared
Dec 24, 2013
INTUITION - TDA, TVA, PARAMETRIC MAPPING
LLZ
System, Image Processing, Radiological
218d
Cleared
Dec 24, 2013
ACUSON
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
244d
Cleared
Dec 20, 2013
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
IYO
System, Imaging, Pulsed Echo, Ultrasonic
23d
Cleared
Dec 20, 2013
ORTHOVIS PREOPERATIVE PLAN
LLZ
System, Image Processing, Radiological
49d
Cleared
Dec 20, 2013
XVWEB
LLZ
System, Image Processing, Radiological
147d
Cleared
Dec 19, 2013
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
LLZ
System, Image Processing, Radiological
35d
Cleared
Dec 19, 2013
SOFTVUE
IYO
System, Imaging, Pulsed Echo, Ultrasonic
433d
Cleared
Dec 17, 2013
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
KXK
Source, Brachytherapy, Radionuclide
84d
Cleared
Dec 16, 2013
SONOSITE EDGE ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
34d
Cleared
Dec 16, 2013
FUSIONSYNC, CHIMAERA FUSIONSYNC
LLZ
System, Image Processing, Radiological
87d
Cleared
Dec 16, 2013
2D PERFUSION
OWB
Interventional Fluoroscopic X-ray System
158d
Cleared
Dec 13, 2013
S-SCAN
LNH
System, Nuclear Magnetic Resonance Imaging
168d
Cleared
Dec 13, 2013
MICRODOSE SI
MUE
Full Field Digital, System, X-ray, Mammographic
273d
Cleared
Dec 13, 2013
HEPAFAT SCAN
LNH
System, Nuclear Magnetic Resonance Imaging
520d
Cleared
Dec 12, 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
LNH
System, Nuclear Magnetic Resonance Imaging
34d
Cleared
Dec 12, 2013
SYNC-RX SYSTEM
OWB
Interventional Fluoroscopic X-ray System
119d
Cleared
Dec 12, 2013
MYOPERFUSION
JAK
System, X-ray, Tomography, Computed
122d
Cleared
Dec 12, 2013
PLATINUM DRF IMAGING SYSTEM
JAA
System, X-ray, Fluoroscopic, Image-intensified
178d
Cleared
Dec 11, 2013
SIDEXIS 4
LLZ
System, Image Processing, Radiological
97d
Cleared
Dec 09, 2013
SYNGO.PLAZA VB10A
LLZ
System, Image Processing, Radiological
119d
Cleared
Dec 05, 2013
ZIEHM VISION RFD
JAA
System, X-ray, Fluoroscopic, Image-intensified
80d
Cleared
Dec 04, 2013
MYLABSEVEN 6400, MYLABALPHA 7400
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
119d
Cleared
Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
LLZ
System, Image Processing, Radiological
47d
Cleared
Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
LLZ
System, Image Processing, Radiological
47d
Cleared
Dec 03, 2013
M-VU BREAST DENSITY
LLZ
System, Image Processing, Radiological
91d
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