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
12771 Radiology devices
8526–8550 of 12771
Cleared Aug 08, 2003
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · Rocket Medical Plc
MQE · Needle, Assisted Reproduction · 39d
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158 · Nucletron Corp.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 118d
Cleared Aug 07, 2003
OTP 1.2
K031349 · Nucletron Corp.
MUJ · System, Planning, Radiation Therapy Treatment · 100d
Cleared Aug 06, 2003
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K032281 · Toshiba America Medical Systems, In.C
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 13d
Cleared Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329 · Medison America, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 8d
Cleared Jul 30, 2003
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · GE Medical Systems
MOS · Coil, Magnetic Resonance, Specialty · 28d
Cleared Jul 25, 2003
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K031980 · Elekta Instrument AB
HAW · Neurological Stereotaxic Instrument · 29d
Cleared Jul 25, 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · Elekta Instrument AB
HAW · Neurological Stereotaxic Instrument · 28d
Cleared Jul 25, 2003
GE LOGIQ 7, MODEL 2354858
K032182 · General Electric Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 8d
Cleared Jul 24, 2003
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
K032174 · Wide Corporation
LLZ · System, Image Processing, Radiological · 8d
Cleared Jul 21, 2003
DUNLEE FORMAT COLLIMATOR FAMILY
K031597 · Philips Medical Systems North America Co.
IZW · Collimator, Automatic, Radiographic · 61d
Cleared Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 12d
Cleared Jul 18, 2003
PRIMA III TOTALSENSE TORSO COIL
K031365 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 79d
Cleared Jul 18, 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504 · Koven Technology, Inc.
KNG · Monitor, Ultrasonic, Fetal · 65d
Cleared Jul 18, 2003
PHILIPS VIEWFORUM 2003
K032096 · Philips Medical Systems
LLZ · System, Image Processing, Radiological · 10d
Cleared Jul 18, 2003
ACUSON CV70 CARDIOVASCULAR SYSTEM
K032111 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 9d
Cleared Jul 17, 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · Philips Medical Systems, Inc.
OWB · Interventional Fluoroscopic X-ray System · 15d
Cleared Jul 11, 2003
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
K031366 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 72d
Cleared Jul 11, 2003
GEMINI 16
K032036 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 10d
Cleared Jul 08, 2003
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
K031929 · Wide Corporation
LLZ · System, Image Processing, Radiological · 15d
Cleared Jul 02, 2003
GE DELTA SOFTWARE OPTION FOR MRI
K031927 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 9d
Cleared Jun 30, 2003
SONOVIEW PRO BY MEDISON CO., LTD.
K031886 · Medison Co., Ltd.
LLZ · System, Image Processing, Radiological · 12d
Cleared Jun 24, 2003
ECLIPSE
K030981 · Varian Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 88d
Cleared Jun 20, 2003
SENSE BODY COIL
K031095 · Philips Medical Systems (Cleveland), Inc.
MOS · Coil, Magnetic Resonance, Specialty · 74d
Cleared Jun 20, 2003
SCANX 10
K031198 · Air Techniques, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 65d

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All categories 12771 LLZ System, Image Processing, Radiological 2028 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1123 LNH System, Nuclear Magnetic Resonance Imaging 996 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 681 IYE Accelerator, Linear, Medical 581 MOS Coil, Magnetic Resonance, Specialty 454 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 KPS System, Tomography, Computed, Emission 386 ITX Transducer, Ultrasonic, Diagnostic 345 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 312 KPR System, X-ray, Stationary 290 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192