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
12795 Radiology devices
8976–9000 of 12795
Cleared Nov 17, 2000
CT CORD IQ OPTION 1.0
K003408 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Nov 16, 2000
ECAT ACCEL PET SCANNER
K002584 · Cti Pet Systems, Inc.
KPS · System, Tomography, Computed, Emission · 87d
Cleared Nov 16, 2000
HRH-63 HEAD ARRAY COIL
K002774 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 71d
Cleared Nov 16, 2000
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K003399 · Sonosite,Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 15d
Cleared Nov 16, 2000
ALLEGRO TB, ALLEGRO N
K003434 · Adac Laboratories
KPS · System, Tomography, Computed, Emission · 10d
Cleared Nov 08, 2000
FREEDOM AUTOMATIC FILM PROCESSOR
K002640 · J. Morita USA, Inc.
IXW · Processor, Radiographic-film, Automatic · 76d
Cleared Nov 08, 2000
QWH-149 WRIST ARRAY COIL
K003331 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 15d
Cleared Nov 08, 2000
OBC-149 BREAST ARRAY COIL
K003340 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 14d
Cleared Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · Brainlab AG
MUJ · System, Planning, Radiation Therapy Treatment · 80d
Cleared Oct 31, 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
K002611 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 70d
Cleared Oct 31, 2000
ECAT PET SCANNER
K002715 · Cti Pet Systems, Inc.
KPS · System, Tomography, Computed, Emission · 61d
Cleared Oct 27, 2000
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · Toshiba America Medical Systems, In.C
LLZ · System, Image Processing, Radiological · 80d
Cleared Oct 26, 2000
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
K002531 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 71d
Cleared Oct 25, 2000
POWER 5000 GENERAL PURPOSE COIL
K002483 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 72d
Cleared Oct 25, 2000
OPART, MODEL MRT-600
K002522 · Toshiba America Mri, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 71d
Cleared Oct 24, 2000
SOMATOM SMILE
K003152 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 14d
Cleared Oct 20, 2000
RADIOCAMERAS EXTRACRANIAL SYSTEM
K000246 · Surgical Navigation Technologies, Inc.
IYE · Accelerator, Linear, Medical · 267d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · Medison America, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 15d
Cleared Oct 19, 2000
VITREA 2, VERSION 2.1
K002519 · Vital Images, Inc.
LLZ · System, Image Processing, Radiological · 65d
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · Hitachi Medical Systems America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 70d
Cleared Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 64d
Cleared Oct 13, 2000
FOCUS
K002147 · Computerized Medical Systems, Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 88d
Cleared Oct 12, 2000
SOMATOM EMOTION MS
K003014 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
K002179 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 84d

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All categories 12795 LLZ System, Image Processing, Radiological 2033 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1126 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 683 IYE Accelerator, Linear, Medical 583 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 292 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192