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
12655 Radiology devices
Cleared
Aug 12, 2008
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
MOS
Coil, Magnetic Resonance, Specialty
54d
Cleared
Aug 12, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Aug 07, 2008
ATLAS-BASED AUTOSEGMENTATION
LHN
System, Radiation Therapy, Charged-particle, Medical
139d
Cleared
Aug 07, 2008
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
IYO
System, Imaging, Pulsed Echo, Ultrasonic
127d
Cleared
Aug 06, 2008
RFVISION, MODEL 9.9D
OWB
Interventional Fluoroscopic X-ray System
133d
Cleared
Aug 06, 2008
SONIX MDP ULTRASOUND SCANNER
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
126d
Cleared
Aug 06, 2008
EDGE PACS
LLZ
System, Image Processing, Radiological
47d
Cleared
Aug 06, 2008
GE VIVID E9 ULTRASOUND
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
30d
Cleared
Aug 06, 2008
ALLTECH ECHOSTAR 1.5 T MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
12d
Cleared
Aug 04, 2008
MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
IYE
Accelerator, Linear, Medical
34d
Cleared
Aug 01, 2008
FIATLUX VISUALIZE
LLZ
System, Image Processing, Radiological
14d
Cleared
Jul 30, 2008
THD SLIDE
JAF
Monitor, Ultrasonic, Nonfetal
70d
Cleared
Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
KPR
System, X-ray, Stationary
30d
Cleared
Jul 29, 2008
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
MUJ
System, Planning, Radiation Therapy Treatment
102d
Cleared
Jul 29, 2008
MAMMO WORKSTATION
LLZ
System, Image Processing, Radiological
48d
Cleared
Jul 29, 2008
RSVP PHANTOM PELVIS, MODEL TLP260
IYE
Accelerator, Linear, Medical
39d
Cleared
Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
LLZ
System, Image Processing, Radiological
17d
Cleared
Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
15d
Cleared
Jul 22, 2008
SAVI APPLICATOR KIT
JAQ
System, Applicator, Radionuclide, Remote-controlled
35d
Cleared
Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
LNH
System, Nuclear Magnetic Resonance Imaging
15d
Cleared
Jul 21, 2008
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
IYE
Accelerator, Linear, Medical
82d
Cleared
Jul 18, 2008
SIMPLANT ORTHO
LLZ
System, Image Processing, Radiological
60d
Cleared
Jul 18, 2008
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
LLZ
System, Image Processing, Radiological
49d
Cleared
Jul 16, 2008
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
LLZ
System, Image Processing, Radiological
106d
Cleared
Jul 16, 2008
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
IYO
System, Imaging, Pulsed Echo, Ultrasonic
14d
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