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
8951–8975 of 12795
Cleared Jan 23, 2001
DIFFUSION TENSOR IMAGING OPTION
K003573 · Ge Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 64d
Cleared Jan 23, 2001
MAGNETOM RHAPSODY SYSTEM
K003628 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 60d
Cleared Jan 23, 2001
VITREA 2 CT PERFUSION OPTION
K003639 · Vital Images, Inc.
JAK · System, X-ray, Tomography, Computed · 60d
Cleared Jan 22, 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · Philips Medical Systems North America, Inc.
LLZ · System, Image Processing, Radiological · 76d
Cleared Jan 22, 2001
VIEW READING STATION
K003688 · Electromed Intl., Ltd.
LLZ · System, Image Processing, Radiological · 53d
Cleared Jan 18, 2001
ACTIVE ARRAY CATHETER, MODEL CS-2000
K001097 · Image-Guided Neurologics, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 289d
Cleared Jan 18, 2001
VIVID 7 WITH SONOPAC, MODEL FB0008XX
K003931 · Ge Medical Systems, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 29d
Cleared Jan 17, 2001
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K003575 · GE Medical Systems
LNI · System, Nuclear Magnetic Resonance Spectroscopic · 58d
Cleared Dec 27, 2000
V SCORE WITH AUTO GATE MODEL TBD
K003230 · Vital Images, Inc.
JAK · System, X-ray, Tomography, Computed · 72d
Cleared Dec 27, 2000
GYROSCAN INTERA 3.0T
K003516 · Philips Medical Systems North America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 43d
Cleared Dec 27, 2000
ALOKA SSD-4000
K003739 · Aloka Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 23d
Cleared Dec 22, 2000
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
K003270 · Nucletron Corp.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 65d
Cleared Dec 22, 2000
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · Medical Advances, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 22d
Cleared Dec 22, 2000
GE ADVANCE NXI PET SYSTEM
K003849 · Ge Medical Systems, Inc.
KPS · System, Tomography, Computed, Emission · 10d
Cleared Dec 21, 2000
MAGNETIC CONCERTO
K003192 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 70d
Cleared Dec 21, 2000
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
K003264 · Ge Medical Systems F.I. Haifa
KPS · System, Tomography, Computed, Emission · 64d
Cleared Dec 21, 2000
INTERACTIVE REAL TIME SCANNING PACKAGE
K003623 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 27d
Cleared Dec 19, 2000
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
K002942 · Philips Medical Systems North America, Inc.
LLZ · System, Image Processing, Radiological · 89d
Cleared Dec 13, 2000
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
K003144 · Medical Advances, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 64d
Cleared Dec 13, 2000
ECAT PET SCANNER
K003241 · Cti Pet Systems, Inc.
KPS · System, Tomography, Computed, Emission · 57d
Cleared Dec 01, 2000
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
K002807 · Acuson Corp.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 84d
Cleared Dec 01, 2000
SIREMOBIL ISO-C 3D
K003266 · Siemens Medical Solutions USA, Inc.
OXO · Image-intensified Fluoroscopic X-ray System, Mobile · 44d
Cleared Nov 29, 2000
DELTA 32 AND DELTA 32 TACT
K002472 · Instrumentarium Imaging, Inc.
IZH · System, X-ray, Mammographic · 110d
Cleared Nov 22, 2000
VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
K003525 · Medison America, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 7d
Cleared Nov 17, 2000
VAGINAL APPLICATOR SHIELDED
K001544 · Mick Radio-Nuclear Instruments, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 183d

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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