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
12782 Radiology devices
Cleared
Jun 05, 2002
PHYSICIAN'S DESKTOP REVIEW
LLZ
System, Image Processing, Radiological
15d
Cleared
May 31, 2002
SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
May 23, 2002
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
JAQ
System, Applicator, Radionuclide, Remote-controlled
30d
Cleared
May 22, 2002
ECLIPSE, HELIOS OPTION
MUJ
System, Planning, Radiation Therapy Treatment
30d
Cleared
May 22, 2002
HISPEED DUAL
JAK
System, X-ray, Tomography, Computed
13d
Cleared
May 21, 2002
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
MOS
Coil, Magnetic Resonance, Specialty
29d
Cleared
May 16, 2002
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
MUI
Media, Coupling, Ultrasound
52d
Cleared
May 09, 2002
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
IYO
System, Imaging, Pulsed Echo, Ultrasonic
78d
Cleared
May 03, 2002
ECHOSCAN, MODEL US-1800
IYO
System, Imaging, Pulsed Echo, Ultrasonic
46d
Cleared
May 01, 2002
OLYMPUS BF TYPE UM40
PSV
Ultrasound Bronchoscope
15d
Cleared
Apr 25, 2002
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
127d
Cleared
Apr 08, 2002
HDR MIAMI APPLICATOR
JAQ
System, Applicator, Radionuclide, Remote-controlled
80d
Cleared
Apr 04, 2002
MEDICAL LE
LLZ
System, Image Processing, Radiological
86d
Cleared
Apr 04, 2002
GE VIVID 3 EXPERT
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
24d
Cleared
Apr 03, 2002
MFCD 118I
LLZ
System, Image Processing, Radiological
85d
Cleared
Apr 03, 2002
IMAGEDESK
LLZ
System, Image Processing, Radiological
85d
Cleared
Apr 03, 2002
SMARTSCORE 3.5
JAK
System, X-ray, Tomography, Computed
12d
Cleared
Mar 26, 2002
M3 (MIRCO-MULTILEAF COLLIMATOR
IYE
Accelerator, Linear, Medical
454d
Cleared
Mar 26, 2002
CARD IQ ANALYSIS II
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Mar 22, 2002
PRONTO
JAK
System, X-ray, Tomography, Computed
86d
Cleared
Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
22d
Cleared
Mar 15, 2002
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
JAA
System, X-ray, Fluoroscopic, Image-intensified
66d
Cleared
Mar 13, 2002
IMPLANT GUIDANCE SYSTEM APPLICATOR SET
JAQ
System, Applicator, Radionuclide, Remote-controlled
69d
Cleared
Mar 13, 2002
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
44d
Cleared
Mar 13, 2002
NVA-63-8 NEUROVASCULAR ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
16d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices