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
12789 Radiology devices
8926–8950 of 12789
Cleared Mar 01, 2001
LOGIQ 500
K010329 · General Electric Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 27d
Cleared Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · GE Medical Systems
MOS · Coil, Magnetic Resonance, Specialty · 68d
Cleared Feb 22, 2001
HRH-127 HEAD ARRAY COIL
K010140 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 36d
Cleared Feb 21, 2001
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K010374 · Sonosite,Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 14d
Cleared Feb 16, 2001
ADVANTAGE WINDOWS CT/PET FUSION
K010336 · Ge Medical Systems, Inc.
LLZ · System, Image Processing, Radiological · 11d
Cleared Feb 14, 2001
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
K003936 · Tomtec Imaging Systems GmbH
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 56d
Cleared Feb 13, 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 63d
Cleared Feb 13, 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc.
KPS · System, Tomography, Computed, Emission · 27d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
K003514 · Shimadzu Medical Systems
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515 · Shimadzu Medical Systems
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 90d
Cleared Feb 02, 2001
P3IMRT TM
K002237 · Adac Laboratories
MUJ · System, Planning, Radiation Therapy Treatment · 193d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429 · Nucletron Corp.
KXK · Source, Brachytherapy, Radionuclide · 178d
Cleared Feb 02, 2001
ODYSSEY LX, MODEL 211320
K003437 · Philips Medical Systems (Cleveland), Inc.
LLZ · System, Image Processing, Radiological · 88d
Cleared Feb 02, 2001
PORTALVISION
K003636 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 70d
Cleared Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 67d
Cleared Feb 02, 2001
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc.
IZH · System, X-ray, Mammographic · 43d
Cleared Feb 02, 2001
X-RAY SYSTEM XR-MX
K004037 · Karl Storz Endoscopy
JAA · System, X-ray, Fluoroscopic, Image-intensified · 36d
Cleared Feb 02, 2001
MODIFICATION TO ARTOSCAN M
K010057 · Biosound Esaote, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 25d
Cleared Jan 30, 2001
CT PERFUSION 2
K010042 · General Electric Co.
JAK · System, X-ray, Tomography, Computed · 25d
Cleared Jan 23, 2001
DIFFUSION TENSOR IMAGING OPTION
K003573 · Ge Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 64d
Cleared Jan 23, 2001
MAGNETOM RHAPSODY SYSTEM
K003628 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 60d
Cleared Jan 23, 2001
VITREA 2 CT PERFUSION OPTION
K003639 · Vital Images, Inc.
JAK · System, X-ray, Tomography, Computed · 60d
Cleared Jan 22, 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · Philips Medical Systems North America, Inc.
LLZ · System, Image Processing, Radiological · 76d
Cleared Jan 22, 2001
VIEW READING STATION
K003688 · Electromed Intl., Ltd.
LLZ · System, Image Processing, Radiological · 53d
Cleared Jan 18, 2001
ACTIVE ARRAY CATHETER, MODEL CS-2000
K001097 · Image-Guided Neurologics, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 289d

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All categories 12789 LLZ System, Image Processing, Radiological 2032 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1124 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 682 IYE Accelerator, Linear, Medical 583 MOS Coil, Magnetic Resonance, Specialty 456 MQB Solid State X-ray Imager (flat Panel/digital Imager) 411 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 347 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