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
Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
45d
Cleared
Oct 02, 2003
MICROMLC
IXI
Block, Beam-shaping, Radiation Therapy
24d
Cleared
Sep 05, 2003
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
IYE
Accelerator, Linear, Medical
88d
Cleared
Jul 25, 2003
GE LOGIQ 7, MODEL 2354858
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
8d
Cleared
Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
12d
Cleared
Jul 18, 2003
ACUSON CV70 CARDIOVASCULAR SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
9d
Cleared
Jul 11, 2003
GEMINI 16
KPS
System, Tomography, Computed, Emission
10d
Cleared
Jun 20, 2003
SENSE BODY COIL
MOS
Coil, Magnetic Resonance, Specialty
74d
Cleared
Jun 09, 2003
GE VIVID 7, MODEL FC0003XX
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
11d
Cleared
May 29, 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
LLZ
System, Image Processing, Radiological
79d
Cleared
Apr 08, 2003
SYNGO COLONOGRAPHY SOFTWARE PACKAGE
LLZ
System, Image Processing, Radiological
11d
Cleared
Mar 28, 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
8d
Cleared
Feb 11, 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
21d
Cleared
Feb 10, 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
JAK
System, X-ray, Tomography, Computed
90d
Cleared
Feb 04, 2003
INFINION SOFTWARE FEATURES
LNH
System, Nuclear Magnetic Resonance Imaging
57d
Cleared
Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
MUJ
System, Planning, Radiation Therapy Treatment
134d
Cleared
Oct 24, 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
LLZ
System, Image Processing, Radiological
29d
Cleared
Sep 12, 2002
GE ROAD WARRIOR PET CT IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
14d
Cleared
Aug 13, 2002
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
IZL
System, X-ray, Mobile
26d
Cleared
Jul 16, 2002
LUNGCARE CT SOFTWARE PACKAGE
JAK
System, X-ray, Tomography, Computed
26d
Cleared
Jul 10, 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
IXA
Cassette, Radiographic Film
30d
Cleared
Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
28d
Cleared
Jun 13, 2002
SYNGO MR 2002B
LNH
System, Nuclear Magnetic Resonance Imaging
78d
Cleared
Jun 06, 2002
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
JAA
System, X-ray, Fluoroscopic, Image-intensified
69d
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