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
Oct 29, 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
LLZ
System, Image Processing, Radiological
54d
Cleared
Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
JAK
System, X-ray, Tomography, Computed
13d
Cleared
Oct 23, 2003
BIOPSY BREAST COIL, MODEL BBC
MOS
Coil, Magnetic Resonance, Specialty
64d
Cleared
Oct 23, 2003
GE MARLIN ULTRASOUND
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
23d
Cleared
Oct 22, 2003
GE LOGIQ BOOK
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
71d
Cleared
Oct 22, 2003
FORTE GAMMA CAMERA SYSTEM
KPS
System, Tomography, Computed, Emission
14d
Cleared
Oct 21, 2003
GE LOGIQ 5 PRO OR EXPERT
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
27d
Cleared
Oct 20, 2003
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
MUH
System, X-ray, Extraoral Source, Digital
13d
Cleared
Oct 16, 2003
MAGNETOM AVANTO MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
79d
Cleared
Oct 16, 2003
HOLOGIC DR IMAGEPRO
LLZ
System, Image Processing, Radiological
59d
Cleared
Oct 16, 2003
SONOLINE ANTARES WITH CLARIFY VE
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
OWB
Interventional Fluoroscopic X-ray System
9d
Cleared
Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
45d
Cleared
Oct 10, 2003
ORTHOPHOS XG DS/CEPH
EHD
Unit, X-ray, Extraoral With Timer
11d
Cleared
Oct 10, 2003
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
10d
Cleared
Oct 10, 2003
HAC-12 AND HAC-30 HEAD ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
10d
Cleared
Oct 10, 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
10d
Cleared
Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
MUJ
System, Planning, Radiation Therapy Treatment
36d
Cleared
Oct 08, 2003
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
30d
Cleared
Oct 08, 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
LLZ
System, Image Processing, Radiological
15d
Cleared
Oct 02, 2003
I-BEAM
IYE
Accelerator, Linear, Medical
86d
Cleared
Oct 02, 2003
MICROMLC
IXI
Block, Beam-shaping, Radiation Therapy
24d
Cleared
Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
LNH
System, Nuclear Magnetic Resonance Imaging
70d
Cleared
Sep 25, 2003
HRK-63-8 KNEE ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
30d
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