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
12508 Radiology devices
Cleared
Nov 25, 2015
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
IYE
Accelerator, Linear, Medical
62d
Cleared
Nov 25, 2015
4Sight
IYO
System, Imaging, Pulsed Echo, Ultrasonic
77d
Cleared
Nov 25, 2015
CORVUS Radiation Therapy Planning System
MUJ
System, Planning, Radiation Therapy Treatment
177d
Cleared
Nov 24, 2015
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
JAK
System, X-ray, Tomography, Computed
406d
Cleared
Nov 20, 2015
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
PGY
Display, Diagnostic Radiology
60d
Cleared
Nov 20, 2015
IQQA Guide
JAK
System, X-ray, Tomography, Computed
177d
Cleared
Nov 20, 2015
ArcCHECK
IYE
Accelerator, Linear, Medical
430d
Cleared
Nov 19, 2015
BladderScan Prime System
IYO
System, Imaging, Pulsed Echo, Ultrasonic
24d
Cleared
Nov 18, 2015
Philips IntelliSpace Cardiovascular
LLZ
System, Image Processing, Radiological
34d
Cleared
Nov 18, 2015
Venue 50
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
55d
Cleared
Nov 18, 2015
8 CH Knee SPEEDER
MOS
Coil, Magnetic Resonance, Specialty
58d
Cleared
Nov 17, 2015
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
PGY
Display, Diagnostic Radiology
49d
Cleared
Nov 17, 2015
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
IYO
System, Imaging, Pulsed Echo, Ultrasonic
92d
Cleared
Nov 16, 2015
UroNav (Version 2.0)
LLZ
System, Image Processing, Radiological
25d
Cleared
Nov 16, 2015
HICAT Air
LLZ
System, Image Processing, Radiological
60d
Cleared
Nov 13, 2015
Multitom Rax
OWB
Interventional Fluoroscopic X-ray System
39d
Cleared
Nov 12, 2015
FUJIFILM SonoSite iViz Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
34d
Cleared
Nov 12, 2015
SOMATOM Emotion 6/16
JAK
System, X-ray, Tomography, Computed
136d
Cleared
Nov 10, 2015
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
MUH
System, X-ray, Extraoral Source, Digital
20d
Cleared
Nov 10, 2015
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
20d
Cleared
Nov 10, 2015
ATAL 9
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
99d
Cleared
Nov 09, 2015
Thermofit
IYE
Accelerator, Linear, Medical
118d
Cleared
Nov 06, 2015
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
58d
Cleared
Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
97d
Cleared
Nov 05, 2015
superDimension Navigation System
JAK
System, X-ray, Tomography, Computed
167d
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