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
12735 Radiology devices
Cleared
Dec 07, 2005
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
LLZ
System, Image Processing, Radiological
12d
Cleared
Dec 07, 2005
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY)
IYO
System, Imaging, Pulsed Echo, Ultrasonic
6d
Cleared
Dec 05, 2005
MEDIQ VERSION 1.0
LLZ
System, Image Processing, Radiological
45d
Cleared
Dec 05, 2005
SYNGO DYNAMICS, VERSION 5.0
LLZ
System, Image Processing, Radiological
27d
Cleared
Dec 02, 2005
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
IYO
System, Imaging, Pulsed Echo, Ultrasonic
95d
Cleared
Nov 30, 2005
IMAGE STAR II
JAA
System, X-ray, Fluoroscopic, Image-intensified
69d
Cleared
Nov 23, 2005
VISION (WITH OFF-LINE REVIEW)
IYE
Accelerator, Linear, Medical
84d
Cleared
Nov 23, 2005
SONOLINE G60 S ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
40d
Cleared
Nov 23, 2005
VIMPLANT
LLZ
System, Image Processing, Radiological
9d
Cleared
Nov 22, 2005
VISTADENT AT COMPLETE, MODEL 3.1
LLZ
System, Image Processing, Radiological
27d
Cleared
Nov 18, 2005
ENCOMPASS SOFTWARE PACKAGE
LLZ
System, Image Processing, Radiological
21d
Cleared
Nov 17, 2005
IMAGECAST PACS
LLZ
System, Image Processing, Radiological
55d
Cleared
Nov 17, 2005
CR-PRO
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
28d
Cleared
Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
22d
Cleared
Nov 17, 2005
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
MOS
Coil, Magnetic Resonance, Specialty
20d
Cleared
Nov 16, 2005
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
LLZ
System, Image Processing, Radiological
62d
Cleared
Nov 16, 2005
COLOR NIO 2MP, E-2320 C
LLZ
System, Image Processing, Radiological
26d
Cleared
Nov 16, 2005
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
MOS
Coil, Magnetic Resonance, Specialty
21d
Cleared
Nov 16, 2005
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Nov 16, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
Nov 14, 2005
SUPERDIMENSION/BRONCHUS PREMIUM
JAK
System, X-ray, Tomography, Computed
34d
Cleared
Nov 10, 2005
ACUSON CYPRESS ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
76d
Cleared
Nov 09, 2005
SMIT SLEEVE
JAQ
System, Applicator, Radionuclide, Remote-controlled
85d
Cleared
Nov 09, 2005
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
MOS
Coil, Magnetic Resonance, Specialty
23d
Cleared
Nov 09, 2005
GE 1.5T SIGNA HDE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
16d
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