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
Feb 06, 2004
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
LLZ
System, Image Processing, Radiological
15d
Cleared
Feb 04, 2004
SIMULIX EVOLUTION
KPQ
System, Simulation, Radiation Therapy
93d
Cleared
Feb 02, 2004
CHASE CARDIAC ANALYSIS SYSTEM
LLZ
System, Image Processing, Radiological
171d
Cleared
Feb 02, 2004
SYNERGY SPINE ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
73d
Cleared
Feb 02, 2004
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
JAQ
System, Applicator, Radionuclide, Remote-controlled
54d
Cleared
Feb 02, 2004
MINXRAY, MODEL HF120/60H POWERPLUS
IZL
System, X-ray, Mobile
21d
Cleared
Jan 30, 2004
CP SLEEVE AND RIVER SLEEVE
KXK
Source, Brachytherapy, Radionuclide
30d
Cleared
Jan 28, 2004
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Jan 21, 2004
INTUITION IMAGE
LHN
System, Radiation Therapy, Charged-particle, Medical
160d
Cleared
Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
JAK
System, X-ray, Tomography, Computed
81d
Cleared
Jan 09, 2004
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
LMC
Camera, Multi Format, Radiological
79d
Cleared
Jan 09, 2004
SPIRIT 5000 CARDIAC COIL
MOS
Coil, Magnetic Resonance, Specialty
66d
Cleared
Jan 08, 2004
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Dec 30, 2003
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
KPQ
System, Simulation, Radiation Therapy
74d
Cleared
Dec 30, 2003
MYOLIGHT
KPS
System, Tomography, Computed, Emission
15d
Cleared
Dec 24, 2003
VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
JAQ
System, Applicator, Radionuclide, Remote-controlled
64d
Cleared
Dec 23, 2003
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
IYE
Accelerator, Linear, Medical
67d
Cleared
Dec 23, 2003
SYNGO PERFUSION-CT
JAK
System, X-ray, Tomography, Computed
13d
Cleared
Dec 19, 2003
EXACTRAC GATING
IYE
Accelerator, Linear, Medical
66d
Cleared
Dec 19, 2003
ALLEGRO IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
15d
Cleared
Dec 19, 2003
SIENET COSMOS
LLZ
System, Image Processing, Radiological
9d
Cleared
Dec 19, 2003
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
LNH
System, Nuclear Magnetic Resonance Imaging
7d
Cleared
Dec 17, 2003
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
MOS
Coil, Magnetic Resonance, Specialty
72d
Cleared
Dec 17, 2003
PELVIC ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
16d
Cleared
Dec 15, 2003
ACCUSOFT
IYE
Accelerator, Linear, Medical
152d
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