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
15507
Total
15488
Cleared
146d
Avg (2y)
1976
Since
4719 Radiology devices
Cleared
Jun 07, 2004
SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
20d
Cleared
May 24, 2004
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
IXA
Cassette, Radiographic Film
97d
Cleared
May 17, 2004
SIEMENS ENHANCED IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
13d
Cleared
Apr 14, 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
85d
Cleared
Apr 07, 2004
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
EHD
Unit, X-ray, Extraoral With Timer
36d
Cleared
Apr 02, 2004
SOMATOM SENSATION 64 AND SENSATION CARDIAC
JAK
System, X-ray, Tomography, Computed
29d
Cleared
Mar 09, 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
IYO
System, Imaging, Pulsed Echo, Ultrasonic
11d
Cleared
Feb 24, 2004
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
OBJ
Catheter, Ultrasound, Intravascular
96d
Cleared
Feb 20, 2004
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
LMC
Camera, Multi Format, Radiological
73d
Cleared
Feb 20, 2004
BRAIN PERFUSION OPTION
JAK
System, X-ray, Tomography, Computed
88d
Cleared
Feb 12, 2004
SIREMOBILE C06
OXO
Image-intensified Fluoroscopic X-ray System, Mobile
30d
Cleared
Jan 28, 2004
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
JAK
System, X-ray, Tomography, Computed
81d
Cleared
Dec 19, 2003
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
LNH
System, Nuclear Magnetic Resonance Imaging
7d
Cleared
Dec 19, 2003
ALLEGRO IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
15d
Cleared
Nov 26, 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
LLZ
System, Image Processing, Radiological
231d
Cleared
Nov 25, 2003
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
20d
Cleared
Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
JAK
System, X-ray, Tomography, Computed
84d
Cleared
Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
JAK
System, X-ray, Tomography, Computed
90d
Cleared
Oct 23, 2003
GE MARLIN ULTRASOUND
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
23d
Cleared
Oct 22, 2003
GE LOGIQ BOOK
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
71d
Cleared
Oct 21, 2003
GE LOGIQ 5 PRO OR EXPERT
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
27d
Cleared
Oct 16, 2003
SONOLINE ANTARES WITH CLARIFY VE
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
Oct 16, 2003
MAGNETOM AVANTO MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
79d
Cleared
Oct 10, 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
10d
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