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
12520 Radiology devices
Cleared
Jun 05, 2015
Ultrasound System SONIMAGE HS1
IYO
System, Imaging, Pulsed Echo, Ultrasonic
46d
Cleared
Jun 05, 2015
Ez3D-i/E3
LLZ
System, Image Processing, Radiological
74d
Cleared
Jun 04, 2015
Collage
LLZ
System, Image Processing, Radiological
52d
Cleared
Jun 03, 2015
MR Core Software
LLZ
System, Image Processing, Radiological
37d
Cleared
Jun 03, 2015
FibroScan
IYO
System, Imaging, Pulsed Echo, Ultrasonic
56d
Cleared
Jun 01, 2015
PROBEAT-V
LHN
System, Radiation Therapy, Charged-particle, Medical
34d
Cleared
Jun 01, 2015
ICIS View
LLZ
System, Image Processing, Radiological
187d
Cleared
May 27, 2015
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
PGY
Display, Diagnostic Radiology
28d
Cleared
May 27, 2015
IntelePACS
LLZ
System, Image Processing, Radiological
69d
Cleared
May 26, 2015
Centricity Universal Viewer
LLZ
System, Image Processing, Radiological
97d
Cleared
May 22, 2015
VentriPoint Medical System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
72d
Cleared
May 22, 2015
Fine Structure Analysis(fineSA)
LLZ
System, Image Processing, Radiological
129d
Cleared
May 22, 2015
SPINEDESIGN Spine Surgery Planning (Software Application)
LLZ
System, Image Processing, Radiological
247d
Cleared
May 20, 2015
Dose Calculator
IYE
Accelerator, Linear, Medical
50d
Cleared
May 20, 2015
E-App
JAQ
System, Applicator, Radionuclide, Remote-controlled
239d
Cleared
May 20, 2015
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
MUJ
System, Planning, Radiation Therapy Treatment
310d
Cleared
May 18, 2015
syngo.CT Dental
JAK
System, X-ray, Tomography, Computed
54d
Cleared
May 15, 2015
ZONARE ZS3 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
May 15, 2015
Active Breathing Coordinator
IYE
Accelerator, Linear, Medical
21d
Cleared
May 15, 2015
.decimal Astroid Dosimetry App
MUJ
System, Planning, Radiation Therapy Treatment
73d
Cleared
May 15, 2015
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways
JAK
System, X-ray, Tomography, Computed
179d
Cleared
May 14, 2015
Planmed Verity
OAS
X-ray, Tomography, Computed, Dental
164d
Cleared
May 12, 2015
syngo.CT Lung CAD
OEB
Lung Computed Tomography System, Computer-aided Detection
187d
Cleared
May 09, 2015
Terason uSmart3200T Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
68d
Cleared
May 08, 2015
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
PGY
Display, Diagnostic Radiology
23d
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