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
Dec 15, 2003
PACS SOFTWARE SOLUTION 2003
LLZ
System, Image Processing, Radiological
27d
Cleared
Dec 12, 2003
VANTAGE PRO ATTENUATION CORRECTION DEVICE
KPS
System, Tomography, Computed, Emission
14d
Cleared
Dec 09, 2003
OB1 OBSTETRICAL DOPPLER
KNG
Monitor, Ultrasonic, Fetal
70d
Cleared
Dec 09, 2003
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
IZI
System, X-ray, Angiographic
69d
Cleared
Dec 09, 2003
ALLURA XPER FD20
OWB
Interventional Fluoroscopic X-ray System
11d
Cleared
Dec 08, 2003
AUTOGEL PAD
MUI
Media, Coupling, Ultrasound
252d
Cleared
Dec 02, 2003
XIO RADIATION TREATMENT PLANNING SYSTEM
IYE
Accelerator, Linear, Medical
88d
Cleared
Nov 26, 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
LLZ
System, Image Processing, Radiological
231d
Cleared
Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
JAQ
System, Applicator, Radionuclide, Remote-controlled
195d
Cleared
Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
14d
Cleared
Nov 25, 2003
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
20d
Cleared
Nov 25, 2003
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
MOS
Coil, Magnetic Resonance, Specialty
15d
Cleared
Nov 20, 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
KPS
System, Tomography, Computed, Emission
23d
Cleared
Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
15d
Cleared
Nov 19, 2003
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
KPR
System, X-ray, Stationary
30d
Cleared
Nov 14, 2003
MOBILETTE XP AND MOBILETT XPHYBRID
IZL
System, X-ray, Mobile
39d
Cleared
Nov 14, 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
MOS
Coil, Magnetic Resonance, Specialty
25d
Cleared
Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
JAK
System, X-ray, Tomography, Computed
90d
Cleared
Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
JAK
System, X-ray, Tomography, Computed
84d
Cleared
Nov 10, 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Nov 06, 2003
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
OEB
Lung Computed Tomography System, Computer-aided Detection
15d
Cleared
Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
KGI
Densitometer, Bone
30d
Cleared
Nov 05, 2003
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Oct 31, 2003
FUKUDA DENSHI MODEL FF SONIC UF-750XT
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
28d
Cleared
Oct 30, 2003
ADVANTAGE 4D OPTION
JAK
System, X-ray, Tomography, Computed
38d
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