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
12871 Radiology devices
Cleared
May 17, 1996
DIAGNOSTIC ULTRASONIC TRANSDUCER
IYO
System, Imaging, Pulsed Echo, Ultrasonic
777d
Cleared
May 14, 1996
VIFS
JAK
System, X-ray, Tomography, Computed
161d
Cleared
May 13, 1996
I-SCAN
IYO
System, Imaging, Pulsed Echo, Ultrasonic
90d
Cleared
May 09, 1996
ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE
LLZ
System, Image Processing, Radiological
184d
Cleared
May 09, 1996
ANALYTICAL REVIEW STATION
IZI
System, X-ray, Angiographic
157d
Cleared
May 07, 1996
DIGITAL IMAGE ACQUISITION SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
466d
Cleared
May 07, 1996
ULTRA COMPACT VIDEO IMAGER
LMC
Camera, Multi Format, Radiological
305d
Cleared
May 07, 1996
ADVANTX LCV+
IZI
System, X-ray, Angiographic
85d
Cleared
May 07, 1996
ECHO-COM FOR MS-WINDOWS VERSION 2.0
LLZ
System, Image Processing, Radiological
77d
Cleared
May 07, 1996
ECHONET
LLZ
System, Image Processing, Radiological
60d
Cleared
May 03, 1996
TANGENT VI TABLE
IXR
Table, Radiographic, Tilting
50d
Cleared
Apr 30, 1996
GE ADVANTAGE WINDOWS REVIEW WORKSTATION
LLZ
System, Image Processing, Radiological
77d
Cleared
Apr 29, 1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
IZH
System, X-ray, Mammographic
94d
Cleared
Apr 23, 1996
STEREOTACTIC BODY FRAME
IYE
Accelerator, Linear, Medical
90d
Cleared
Apr 22, 1996
PID-1 PRECISION INTELLIGENT DOSIMETER
IYE
Accelerator, Linear, Medical
203d
Cleared
Apr 22, 1996
THERAVIEW
IYE
Accelerator, Linear, Medical
77d
Cleared
Apr 19, 1996
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
LNH
System, Nuclear Magnetic Resonance Imaging
88d
Cleared
Apr 17, 1996
INTRACAVITY TRANSDUCERS
ITX
Transducer, Ultrasonic, Diagnostic
252d
Cleared
Apr 17, 1996
IMAGEFUSION
LLZ
System, Image Processing, Radiological
103d
Cleared
Apr 17, 1996
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
LMD
System, Digital Image Communications, Radiological
83d
Cleared
Apr 15, 1996
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
496d
Cleared
Apr 15, 1996
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
JAK
System, X-ray, Tomography, Computed
410d
Cleared
Apr 15, 1996
OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
IYO
System, Imaging, Pulsed Echo, Ultrasonic
353d
Cleared
Apr 12, 1996
BIOSENSOR BIDOP VASCULAR TEST SYSTEM
JAF
Monitor, Ultrasonic, Nonfetal
640d
Cleared
Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
LNH
System, Nuclear Magnetic Resonance Imaging
207d
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