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
12774 Radiology devices
8601–8625 of 12774
Cleared Feb 12, 2003
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147 · Varian Medical Systems, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 58d
Cleared Feb 11, 2003
TECHNOS MP, MODEL AU6
K023255 · Biosound Esaote, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 134d
Cleared Feb 11, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K023401 · Pentax Precision Instrument Corp.
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 125d
Cleared Feb 11, 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · General Electric Co.
KPS · System, Tomography, Computed, Emission · 21d
Cleared Feb 10, 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 90d
Cleared Feb 05, 2003
CARDIUS-1 AND CARDIS-2
K030085 · Digirad Corp.
KPS · System, Tomography, Computed, Emission · 27d
Cleared Feb 04, 2003
GE DISCOVERY LS SYSTEM
K023988 · GE Medical Systems
KPS · System, Tomography, Computed, Emission · 64d
Cleared Feb 04, 2003
PANORAMA ENHANCEMENTS
K024042 · Philips Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 60d
Cleared Feb 04, 2003
INFINION SOFTWARE FEATURES
K024066 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 57d
Cleared Feb 04, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K024187 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 47d
Cleared Jan 29, 2003
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
K030191 · Teratech Corp.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 8d
Cleared Jan 24, 2003
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
K023650 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 86d
Cleared Jan 24, 2003
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
K023970 · Medis Medical Imaging Systems BV
IZI · System, X-ray, Angiographic · 56d
Cleared Jan 22, 2003
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
K030064 · Sonosite,Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 15d
Cleared Jan 17, 2003
BARCO MEDIS 5MP2 AURA
K023533 · Barco N.V.
LLZ · System, Image Processing, Radiological · 88d
Cleared Jan 16, 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · Ge Medical Systems, Inc.
OWB · Interventional Fluoroscopic X-ray System · 27d
Cleared Jan 15, 2003
JUPITER PROCESSING AND REVIEW WORKSTATION
K024137 · Ge Medical Systems, Inc.
LLZ · System, Image Processing, Radiological · 30d
Cleared Jan 09, 2003
QWH-250-PAN WRIST ARRAY COIL
K024209 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 20d
Cleared Jan 09, 2003
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
K024352 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 10d
Cleared Jan 09, 2003
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
K024354 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 10d
Cleared Jan 07, 2003
ACCULEAF
K021338 · Direx Systems Corp.
IYE · Accelerator, Linear, Medical · 256d
Cleared Jan 07, 2003
OBC-250-PAN BREAST ARRAY COIL
K024208 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 18d
Cleared Jan 03, 2003
TROPHYPAN
K023346 · Trophy Radiologie
MUH · System, X-ray, Extraoral Source, Digital · 88d
Cleared Dec 23, 2002
CHAMPION 5000 PERIPHERAL VASCULAR COIL
K023247 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 84d
Cleared Dec 23, 2002
CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023322 · Barco N.V.
LLZ · System, Image Processing, Radiological · 80d

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All categories 12774 LLZ System, Image Processing, Radiological 2029 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 582 MOS Coil, Magnetic Resonance, Specialty 454 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 KPS System, Tomography, Computed, Emission 387 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