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
12750 Radiology devices
Cleared
Nov 16, 2004
RESTITU
IYE
Accelerator, Linear, Medical
120d
Cleared
Nov 16, 2004
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
Nov 15, 2004
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
LHO
Instrument, Quality-assurance, Radiologic
45d
Cleared
Nov 12, 2004
SENSATOUCH
IYO
System, Imaging, Pulsed Echo, Ultrasonic
84d
Cleared
Nov 12, 2004
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
MOS
Coil, Magnetic Resonance, Specialty
43d
Cleared
Nov 10, 2004
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
ITX
Transducer, Ultrasonic, Diagnostic
127d
Cleared
Nov 10, 2004
VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
90d
Cleared
Nov 10, 2004
ACCUPACH V
IYO
System, Imaging, Pulsed Echo, Ultrasonic
37d
Cleared
Nov 10, 2004
TRAUMACAD 1.2
LLZ
System, Image Processing, Radiological
29d
Cleared
Nov 09, 2004
GEMINI GXL
KPS
System, Tomography, Computed, Emission
15d
Cleared
Nov 08, 2004
SUPERDIMENSION/BRONCHUS
JAK
System, X-ray, Tomography, Computed
61d
Cleared
Nov 08, 2004
IMAGE MEDICAL ACQUISITION STATION (IMAS)
LLZ
System, Image Processing, Radiological
39d
Cleared
Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
MOS
Coil, Magnetic Resonance, Specialty
42d
Cleared
Nov 05, 2004
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT
MUI
Media, Coupling, Ultrasound
42d
Cleared
Nov 03, 2004
BEST BREAST BRACHYTHERAPY APPLICATOR
JAQ
System, Applicator, Radionuclide, Remote-controlled
42d
Cleared
Nov 03, 2004
HI-ART SYSTEM
MUJ
System, Planning, Radiation Therapy Treatment
30d
Cleared
Nov 03, 2004
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
MOS
Coil, Magnetic Resonance, Specialty
19d
Cleared
Nov 03, 2004
JETSTREAM WORKSPACE
KPS
System, Tomography, Computed, Emission
15d
Cleared
Nov 03, 2004
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
8d
Cleared
Nov 02, 2004
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
IZL
System, X-ray, Mobile
15d
Cleared
Nov 02, 2004
PHILIPS ORTHOPAEDIC APPLICATIONS
LLZ
System, Image Processing, Radiological
15d
Cleared
Oct 29, 2004
MAMMOTEST
IZH
System, X-ray, Mammographic
87d
Cleared
Oct 29, 2004
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
KGI
Densitometer, Bone
46d
Cleared
Oct 29, 2004
ON-BOARD IMAGER DEVICE
IYE
Accelerator, Linear, Medical
28d
Cleared
Oct 29, 2004
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
OWB
Interventional Fluoroscopic X-ray System
22d
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