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
Jul 17, 2002
SURGERY AND ACCESSORIES
LLZ
System, Image Processing, Radiological
90d
Cleared
Jul 16, 2002
LUNGCARE CT SOFTWARE PACKAGE
JAK
System, X-ray, Tomography, Computed
26d
Cleared
Jul 13, 2002
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
KXK
Source, Brachytherapy, Radionuclide
79d
Cleared
Jul 12, 2002
MEDICAL ADMINISTRATOR
LLZ
System, Image Processing, Radiological
184d
Cleared
Jul 12, 2002
EIZO, MODEL FC-2091
LLZ
System, Image Processing, Radiological
14d
Cleared
Jul 10, 2002
ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
IYO
System, Imaging, Pulsed Echo, Ultrasonic
131d
Cleared
Jul 10, 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
IXA
Cassette, Radiographic Film
30d
Cleared
Jul 09, 2002
CYPRESS ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
61d
Cleared
Jul 09, 2002
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
JAK
System, X-ray, Tomography, Computed
15d
Cleared
Jul 02, 2002
SCEPTRE-VS
LLZ
System, Image Processing, Radiological
68d
Cleared
Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
28d
Cleared
Jul 02, 2002
Q LAB SOFTWARE
LLZ
System, Image Processing, Radiological
15d
Cleared
Jun 27, 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
MOS
Coil, Magnetic Resonance, Specialty
79d
Cleared
Jun 21, 2002
CINESCAN S
IYO
System, Imaging, Pulsed Echo, Ultrasonic
30d
Cleared
Jun 19, 2002
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
FDS
Gastroscope And Accessories, Flexible/rigid
12d
Cleared
Jun 17, 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
IZL
System, X-ray, Mobile
80d
Cleared
Jun 13, 2002
SYNGO MR 2002B
LNH
System, Nuclear Magnetic Resonance Imaging
78d
Cleared
Jun 13, 2002
MAMMOPATH
MWP
Cabinet, X-ray System
69d
Cleared
Jun 13, 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
MOS
Coil, Magnetic Resonance, Specialty
38d
Cleared
Jun 12, 2002
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
29d
Cleared
Jun 12, 2002
OBC-127 BREAST ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
29d
Cleared
Jun 07, 2002
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
EAG
Cephalometer
38d
Cleared
Jun 06, 2002
GPF-29 GENERAL PURPOSE COIL SET
MOS
Coil, Magnetic Resonance, Specialty
83d
Cleared
Jun 06, 2002
M3 (MICRO-MULTILEAF COLLIMATOR)
IYE
Accelerator, Linear, Medical
80d
Cleared
Jun 06, 2002
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
JAA
System, X-ray, Fluoroscopic, Image-intensified
69d
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