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
12632 Radiology devices
Cleared
Jun 17, 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
IYO
System, Imaging, Pulsed Echo, Ultrasonic
223d
Cleared
Jun 17, 2010
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
230d
Cleared
Jun 17, 2010
O-ARM IMAGING SYSTEM
OXO
Image-intensified Fluoroscopic X-ray System, Mobile
301d
Cleared
Jun 16, 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
MUJ
System, Planning, Radiation Therapy Treatment
56d
Cleared
Jun 16, 2010
10 X 10 VISION
MWP
Cabinet, X-ray System
351d
Cleared
May 26, 2010
SYNGO.CT CORONARY ANALYSIS
JAK
System, X-ray, Tomography, Computed
82d
Cleared
May 21, 2010
SONIC SHOT GX
IZQ
Injector, Contrast Medium, Automatic
344d
Cleared
May 14, 2010
MRI PATIENT POSITIONING DEVICES
LNH
System, Nuclear Magnetic Resonance Imaging
161d
Cleared
May 13, 2010
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
OQQ
Diagnostic Ultrasonic Transducer, Robotic
301d
Cleared
May 12, 2010
PLANMECA PROMAX 3D MAX
MUH
System, X-ray, Extraoral Source, Digital
174d
Cleared
May 12, 2010
MINXRAY, MODEL: BPD60
EHD
Unit, X-ray, Extraoral With Timer
378d
Cleared
May 07, 2010
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
LLZ
System, Image Processing, Radiological
64d
Cleared
May 05, 2010
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
42d
Cleared
Apr 30, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
16d
Cleared
Apr 30, 2010
CAAS QVA 3D, CAAS QCA 3D
LLZ
System, Image Processing, Radiological
87d
Cleared
Apr 29, 2010
DOPPLER FETAL HEARTBEAT RATE DETECTOR
KNG
Monitor, Ultrasonic, Fetal
427d
Cleared
Apr 26, 2010
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
MUH
System, X-ray, Extraoral Source, Digital
279d
Cleared
Apr 23, 2010
ERGO IMAGING SYSTEM
IYX
Camera, Scintillation (gamma)
30d
Cleared
Apr 23, 2010
MINXRAY MODEL CMDR-2S
IZL
System, X-ray, Mobile
65d
Cleared
Apr 14, 2010
SYNAPSE OBLIQUUS MIP/MPR/FUSION
LLZ
System, Image Processing, Radiological
15d
Cleared
Apr 06, 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
IZH
System, X-ray, Mammographic
27d
Cleared
Apr 05, 2010
S-SCAN, MODEL 9800020010
MOS
Coil, Magnetic Resonance, Specialty
27d
Cleared
Mar 24, 2010
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
MUH
System, X-ray, Extraoral Source, Digital
48d
Cleared
Mar 24, 2010
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
61d
Cleared
Mar 18, 2010
STORM-BASE 2.0
LLZ
System, Image Processing, Radiological
118d
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