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
12756 Radiology devices
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
Cleared
Oct 29, 2004
C-PET PLUS IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
15d
Cleared
Oct 29, 2004
AUTOSPECS
KPS
System, Tomography, Computed, Emission
14d
Cleared
Oct 28, 2004
ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
IYO
System, Imaging, Pulsed Echo, Ultrasonic
15d
Cleared
Oct 28, 2004
SIENET COSMOS (VERSION V15A)
LLZ
System, Image Processing, Radiological
15d
Cleared
Oct 27, 2004
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
IYO
System, Imaging, Pulsed Echo, Ultrasonic
14d
Cleared
Oct 22, 2004
UNFORS PATIENT SKIN DOSIMETER (PSD)
JAA
System, X-ray, Fluoroscopic, Image-intensified
22d
Cleared
Oct 22, 2004
DIGITAL DETECTOR, MODEL GR17
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
10d
Cleared
Oct 21, 2004
IMPLANTMASTER
LLZ
System, Image Processing, Radiological
66d
Cleared
Oct 21, 2004
RADIOTHERAPY SOLUTION BASED ON CR
IXK
System, Imaging, X-ray, Electrostatic
15d
Cleared
Oct 20, 2004
SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
50d
Cleared
Oct 20, 2004
RSA-CMS
LLZ
System, Image Processing, Radiological
49d
Cleared
Oct 20, 2004
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
LMA
Digitizer, Image, Radiological
37d
Cleared
Oct 20, 2004
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Oct 19, 2004
SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
ITX
Transducer, Ultrasonic, Diagnostic
40d
Cleared
Oct 19, 2004
DYNACT
IZI
System, X-ray, Angiographic
21d
Cleared
Oct 19, 2004
COLON CAR 1.2
NWE
Colon Computed Tomography System, Computer Aided Detection
20d
Cleared
Oct 19, 2004
IPACS CARDIO
LLZ
System, Image Processing, Radiological
13d
Cleared
Oct 13, 2004
CDX DIGITAL X-RAY IMAGING SYSTEM
MUH
System, X-ray, Extraoral Source, Digital
12d
Cleared
Oct 08, 2004
IQQA-CHEST SOFTWARE PACKAGE
OMJ
Chest X-ray Computer Aided Detection
35d
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