FDA Review Panel · RA

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
12782 Radiology devices
8776–8800 of 12782
Cleared Mar 01, 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K013054 · Konica Minolta Medical & Graphic, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 171d
Cleared Feb 28, 2002
ADVANTAGE WORKSTATION 4.1
K020483 · GE Medical Systems
LLZ · System, Image Processing, Radiological · 15d
Cleared Feb 22, 2002
CP-SLEEVE
K013975 · Cp Medical
KXK · Source, Brachytherapy, Radionuclide · 81d
Cleared Feb 22, 2002
PORTABLE X-RAY UNITS
K020436 · Sedecal., Sa.
IZL · System, X-ray, Mobile · 14d
Cleared Feb 15, 2002
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
K020385 · Toshiba America Medical Systems, In.C
JAK · System, X-ray, Tomography, Computed · 10d
Cleared Feb 13, 2002
OMNIA X/XS ULTRASOUND SYSTEM
K020353 · Siemens Medical Systems, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 9d
Cleared Feb 12, 2002
E-SCAN XQ
K020164 · Biosound Esaote, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 26d
Cleared Feb 06, 2002
MARK 5000 QUADRATURE SHOULDER COIL
K013854 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 78d
Cleared Feb 06, 2002
LOGIQ 3
K020263 · General Electric Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 12d
Cleared Feb 05, 2002
CTL BODY / SPINE ARRAY COIL
K014086 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 56d
Cleared Feb 04, 2002
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · Pentax Precision Instrument Corp.
FDS · Gastroscope And Accessories, Flexible/rigid · 91d
Cleared Feb 04, 2002
VERAVIEWEPOCS, MODEL VE
K013955 · J. Morita USA, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 66d
Cleared Feb 01, 2002
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K013826 · Siemens Medical Systems, Inc.
KPR · System, X-ray, Stationary · 74d
Cleared Feb 01, 2002
SCANX
K013893 · Air Techniques, Inc.
MUH · System, X-ray, Extraoral Source, Digital · 70d
Cleared Feb 01, 2002
EXS-63 SMALL EXTREMITY ARRAY COIL
K020036 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 28d
Cleared Jan 28, 2002
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
K013922 · Barco N.V.
LLZ · System, Image Processing, Radiological · 62d
Cleared Jan 24, 2002
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
K013636 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 80d
Cleared Jan 24, 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · Cp Medical
KXK · Source, Brachytherapy, Radionuclide · 52d
Cleared Jan 22, 2002
BODY ARRAY COIL
K013594 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 84d
Cleared Jan 22, 2002
PREMIER III PHASED ARRAY CTL SPINE COIL
K013595 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 84d
Cleared Jan 22, 2002
INFINION 0.6T MR IMAGING SYSTEM
K013858 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 62d
Cleared Jan 18, 2002
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894 · Philips Medical Systems North America, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 56d
Cleared Jan 16, 2002
KONICA LASER IMAGER, DRYPRO MODEL 751/752
K013052 · Konica Minolta Medical & Graphic, Inc.
LMC · Camera, Multi Format, Radiological · 127d
Cleared Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · Planmed OY
IZH · System, X-ray, Mammographic · 71d
Cleared Jan 16, 2002
LOGIQBOOK
K014206 · General Electric Co.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 26d

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All categories 12782 LLZ System, Image Processing, Radiological 2031 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1123 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 681 IYE Accelerator, Linear, Medical 582 MOS Coil, Magnetic Resonance, Specialty 455 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 346 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 313 KPR System, X-ray, Stationary 291 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192