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
12831 Radiology devices
9176–9200 of 12831
Cleared Feb 14, 2000
ISOCENTRIC BEAM CHECKER
K993959 · Mick Radio-Nuclear Instruments, Inc.
IYE · Accelerator, Linear, Medical · 84d
Cleared Feb 14, 2000
PERMA-DOC PHANTOM
K993960 · Mick Radio-Nuclear Instruments, Inc.
IYE · Accelerator, Linear, Medical · 84d
Cleared Feb 14, 2000
ISSA PHAROS
K994054 · Vams Tec, D.O.O.
LLZ · System, Image Processing, Radiological · 76d
Cleared Feb 14, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K994345 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 53d
Cleared Feb 10, 2000
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
K992467 · Dba Systems, Inc.
LMA · Digitizer, Image, Radiological · 202d
Cleared Feb 10, 2000
MU PLUS
K992689 · Rad Therapy Solutions, Inc.
IYE · Accelerator, Linear, Medical · 184d
Cleared Feb 10, 2000
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
K993861 · Fujifilm Medical System U.S.A., Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 87d
Cleared Feb 10, 2000
MEDX INTECAM INTERFACE
K993893 · Medx, Inc.
KPS · System, Tomography, Computed, Emission · 86d
Cleared Feb 10, 2000
PR3 ULTRASOUND SYSTEM
K993978 · Carolina Medical, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 78d
Cleared Feb 06, 2000
EXCELART WITH PIANISSIMO
K993803 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 89d
Cleared Feb 04, 2000
BARCOMED 2MP2
K000015 · Barco N.V.
LLZ · System, Image Processing, Radiological · 32d
Cleared Feb 04, 2000
KAC-63 KNEE ARRAY COIL
K993898 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 80d
Cleared Feb 04, 2000
MR ENHANCER
K994117 · I.Z.I. Corp.
LNH · System, Nuclear Magnetic Resonance Imaging · 60d
Cleared Feb 04, 2000
INTURIS SUITE
K994210 · Philips Medical Systems, Inc.
LLZ · System, Image Processing, Radiological · 52d
Cleared Feb 04, 2000
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315 · Siemens Medical Solutions USA, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 44d
Cleared Feb 02, 2000
SUPER TISSUE
K993742 · I.Z.I. Corp.
IYE · Accelerator, Linear, Medical · 90d
Cleared Feb 02, 2000
PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO
K993750 · Problem Solving Concepts, Inc.
LLZ · System, Image Processing, Radiological · 89d
Cleared Jan 31, 2000
SHARP 9000 PHASED ARRAY BRAIN COIL
K994042 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 63d
Cleared Jan 20, 2000
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
K993598 · Vidar Systems Corp.
LMA · Digitizer, Image, Radiological · 87d
Cleared Jan 20, 2000
MRI EQUIPMENT COVER
K993682 · Image-Guided Neurologics, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 80d
Cleared Jan 19, 2000
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
K000030 · Medison America, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 14d
Cleared Jan 18, 2000
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K992811 · Epic Medical Equipment Services, Inc.
HFM · Monitor, Uterine Contraction, External (for Use In Clinic) · 151d
Cleared Jan 18, 2000
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
K993574 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 89d
Cleared Jan 18, 2000
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
K993599 · Vidar Systems Corp.
LMA · Digitizer, Image, Radiological · 85d
Cleared Jan 18, 2000
SHARPVIEW IMAGE ENHANCEMENT SYSTEM
K993802 · Context Vision AB
LLZ · System, Image Processing, Radiological · 70d

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All categories 12831 LLZ System, Image Processing, Radiological 2037 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1128 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 749 IYO System, Imaging, Pulsed Echo, Ultrasonic 686 IYE Accelerator, Linear, Medical 586 MOS Coil, Magnetic Resonance, Specialty 457 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 314 KPR System, X-ray, Stationary 296 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 193