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
12784 Radiology devices
8851–8875 of 12784
Cleared Sep 19, 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · Nucletron Corp.
KPR · System, X-ray, Stationary · 70d
Cleared Sep 18, 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · GE Medical Systems
KPS · System, Tomography, Computed, Emission · 29d
Cleared Sep 12, 2001
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K012867 · Medison America, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 16d
Cleared Sep 12, 2001
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
K012887 · Medison America, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d
Cleared Sep 07, 2001
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
K012836 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Sep 06, 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · General Electric Co.
KPS · System, Tomography, Computed, Emission · 28d
Cleared Sep 04, 2001
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical
KXK · Source, Brachytherapy, Radionuclide · 187d
Cleared Aug 30, 2001
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
K012253 · Aloka Co., Ltd.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 43d
Cleared Aug 29, 2001
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
K012080 · Aloka Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 57d
Cleared Aug 29, 2001
E-SCAN MRI SYSTEM
K012728 · Biosound Esaote, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 14d
Cleared Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657 · Mick Radio-Nuclear Instruments, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 90d
Cleared Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
K011886 · Olympus America, Inc.
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 73d
Cleared Aug 23, 2001
GE LOGIQ A100 MP, MODEL 2272413
K012560 · General Electric Co.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604 · Ge Medical Systems, Inc.
LNI · System, Nuclear Magnetic Resonance Spectroscopic · 90d
Cleared Aug 14, 2001
MODEL 235GE-64
K011608 · Medical Advances, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 81d
Cleared Aug 14, 2001
HNC-127 NEUROVASCULAR ARRAY COIL
K012353 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 20d
Cleared Aug 10, 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · Eastman Kodak Company
LLZ · System, Image Processing, Radiological · 30d
Cleared Aug 10, 2001
HISPEED X/I SMART GANTRY OPTION
K012385 · Ge Medical Systems, Inc.
JAK · System, X-ray, Tomography, Computed · 14d
Cleared Aug 10, 2001
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K012389 · Ge Medical Systems, Inc.
KPR · System, X-ray, Stationary · 14d
Cleared Aug 07, 2001
CT COLONOGRAPHY/NAVIGATOR2
K012313 · Ge Medical Systems, Inc.
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Aug 03, 2001
IN SPACE 3D
K011447 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 84d
Cleared Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 21d
Cleared Jul 31, 2001
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
K003285 · Brainlab AG
IYE · Accelerator, Linear, Medical · 285d
Cleared Jul 31, 2001
QCU ANALYTICAL SOFTWARE PACKAGE
K011582 · Medis Medical Imaging Systems BV
LLZ · System, Image Processing, Radiological · 69d
Cleared Jul 31, 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
K012099 · Totoku Electric Co., Ltd.
LLZ · System, Image Processing, Radiological · 26d

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All categories 12784 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 456 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 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