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
12803 Radiology devices
9151–9175 of 12803
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
Cleared Jan 18, 2000
LUMAGEM SCINTILLATION CAMERA
K993813 · Gamma Medica
IYX · Camera, Scintillation (gamma) · 69d
Cleared Jan 18, 2000
PHASED ARRAY KNEE AND FOOT COIL
K994040 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 50d
Cleared Jan 14, 2000
PHARMASEED, MODEL BT-103-1
K992007 · Syncor Pharmaceuticals, Inc.
KXK · Source, Brachytherapy, Radionuclide · 213d

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All categories 12803 LLZ System, Image Processing, Radiological 2033 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1127 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 685 IYE Accelerator, Linear, Medical 585 MOS Coil, Magnetic Resonance, Specialty 456 MQB Solid State X-ray Imager (flat Panel/digital Imager) 411 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 294 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192