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
4746 Radiology devices
Cleared
Apr 04, 2002
GE VIVID 3 EXPERT
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
24d
Cleared
Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
22d
Cleared
Mar 13, 2002
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
44d
Cleared
Feb 06, 2002
LOGIQ 3
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
12d
Cleared
Jan 22, 2002
INFINION 0.6T MR IMAGING SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
62d
Cleared
Jan 16, 2002
LOGIQBOOK
IYO
System, Imaging, Pulsed Echo, Ultrasonic
26d
Cleared
Dec 07, 2001
KODAK DIRECTVIEW TABLETOP CASSETTE
IXA
Cassette, Radiographic Film
30d
Cleared
Oct 31, 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
LNH
System, Nuclear Magnetic Resonance Imaging
89d
Cleared
Oct 26, 2001
ADVANCED LUNG ANALYSIS-1
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Sep 06, 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
KPS
System, Tomography, Computed, Emission
28d
Cleared
Aug 23, 2001
GE LOGIQ A100 MP, MODEL 2272413
IYO
System, Imaging, Pulsed Echo, Ultrasonic
15d
Cleared
Aug 10, 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
LLZ
System, Image Processing, Radiological
30d
Cleared
Aug 03, 2001
IN SPACE 3D
JAK
System, X-ray, Tomography, Computed
84d
Cleared
Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
LNH
System, Nuclear Magnetic Resonance Imaging
80d
Cleared
Jun 26, 2001
SYNGO MULTIMODALITY WORKSTATION
LLZ
System, Image Processing, Radiological
89d
Cleared
Jun 15, 2001
MX8000 V5.0 CT SYSTEM
JAK
System, X-ray, Tomography, Computed
88d
Cleared
May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
LNH
System, Nuclear Magnetic Resonance Imaging
77d
Cleared
May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
LNH
System, Nuclear Magnetic Resonance Imaging
61d
Cleared
Apr 12, 2001
U04
OWB
Interventional Fluoroscopic X-ray System
14d
Cleared
Mar 01, 2001
LOGIQ 500
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
27d
Cleared
Feb 13, 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
KPS
System, Tomography, Computed, Emission
27d
Cleared
Feb 13, 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
LNH
System, Nuclear Magnetic Resonance Imaging
63d
Cleared
Feb 02, 2001
OPDIMA
IZH
System, X-ray, Mammographic
43d
Cleared
Feb 02, 2001
ODYSSEY LX, MODEL 211320
LLZ
System, Image Processing, Radiological
88d
Cleared
Jan 30, 2001
CT PERFUSION 2
JAK
System, X-ray, Tomography, Computed
25d
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