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
12855 Radiology devices
10001–10025 of 12855
Cleared Aug 06, 1997
COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
K963290 · Endosonics Corp.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 350d
Cleared Aug 05, 1997
ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
K963451 · Topslane
IYE · Accelerator, Linear, Medical · 336d
Cleared Aug 05, 1997
PM 2002 CC PROLINE
K970812 · Planmeca Oy
EHD · Unit, X-ray, Extraoral With Timer · 153d
Cleared Aug 05, 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 90d
Cleared Aug 04, 1997
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
K970508 · Shimadzu Medical Systems
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 175d
Cleared Jul 30, 1997
INTRACAVITY NEEDLE GUIDE KIT
K955668 · Arlanda Medicinska Instrument Co. AB
ITX · Transducer, Ultrasonic, Diagnostic · 595d
Cleared Jul 29, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964886 · GE Medical Systems
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 235d
Cleared Jul 29, 1997
VELOS CONSTANCY CHECK DEVICE, MODEL 55-145
K970384 · Aktina Medical Physics Corp.
IYE · Accelerator, Linear, Medical · 176d
Cleared Jul 29, 1997
THE MIDVIEW-MEDCON'S DICOM VIEWER
K971181 · Medcon , Ltd.
IZI · System, X-ray, Angiographic · 120d
Cleared Jul 29, 1997
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY
K972672 · Barzell-Whitmore Maroon Bells, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 13d
Cleared Jul 25, 1997
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
K971660 · Olympus America, Inc.
FDS · Gastroscope And Accessories, Flexible/rigid · 80d
Cleared Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 79d
Cleared Jul 24, 1997
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
K972348 · Hewlett-Packard Co.
ITX · Transducer, Ultrasonic, Diagnostic · 30d
Cleared Jul 23, 1997
TARGET 2 VERSION 1.1
K965010 · GE Medical Systems
IYE · Accelerator, Linear, Medical · 219d
Cleared Jul 23, 1997
CARDIAC PHASED ARRAY COIL
K971667 · GE Medical Systems
MOS · Coil, Magnetic Resonance, Specialty · 78d
Cleared Jul 23, 1997
SLED, FINGER, HANDLE
K971942 · Biosound Esaote, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 57d
Cleared Jul 22, 1997
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM
K962950 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 358d
Cleared Jul 21, 1997
VERIDOSE V (FIVE), MODEL NUMBER 37-705
K964952 · Victoreen, Inc.
JAD · System, Therapeutic, X-ray · 223d
Cleared Jul 21, 1997
FLEXART V3.5 SOFTWARE
K970573 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 157d
Cleared Jul 15, 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068 · Toshiba America Medical Systems, In.C
LNH · System, Nuclear Magnetic Resonance Imaging · 209d
Cleared Jul 14, 1997
DTX-100 BONE DENSITOMETER
K963789 · Osteometer Meditech A/S
KGI · Densitometer, Bone · 297d
Cleared Jul 14, 1997
TARGOBEAM
K970819 · Ferguson Medical
JAK · System, X-ray, Tomography, Computed · 131d
Cleared Jul 14, 1997
ECHOVACS
K971776 · Vmi Technologies
LLZ · System, Image Processing, Radiological · 62d
Cleared Jul 10, 1997
TRANS VAGINAL NEEDLE GUIDE
K971722 · Protek Medical Products, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 62d
Cleared Jul 09, 1997
THERAPLAN PLUS VERSION 1.2
K970236 · Theratronics, Inc.
IYE · Accelerator, Linear, Medical · 169d

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All categories 12855 LLZ System, Image Processing, Radiological 2039 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1133 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 750 IYO System, Imaging, Pulsed Echo, Ultrasonic 688 IYE Accelerator, Linear, Medical 588 MOS Coil, Magnetic Resonance, Specialty 459 MQB Solid State X-ray Imager (flat Panel/digital Imager) 417 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 347 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 315 KPR System, X-ray, Stationary 296 MUJ System, Planning, Radiation Therapy Treatment 238 MUH System, X-ray, Extraoral Source, Digital 193