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
12797 Radiology devices
9026–9050 of 12797
Cleared Aug 14, 2000
HAC-300 HEAD ARRAY COIL
K001944 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 49d
Cleared Aug 08, 2000
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
K002225 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 15d
Cleared Aug 02, 2000
SIGMA
K001928 · Instrumentarium Imaging, Inc.
MUH · System, X-ray, Extraoral Source, Digital · 37d
Cleared Aug 01, 2000
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
K001400 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 90d
Cleared Aug 01, 2000
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K002185 · Medison America, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 13d
Cleared Aug 01, 2000
EXPLORER CVS TRANSCRANIAL DOPPLER
K990517 · Diagnostic Medical Systems
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 530d
Cleared Jul 21, 2000
PROTON BEAM THERAPY SYSTEM (PBTS)
K992414 · Optivus Technology, Inc.
LHN · System, Radiation Therapy, Charged-particle, Medical · 367d
Cleared Jul 17, 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K001582 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 56d
Cleared Jul 17, 2000
PHARMASEED, MODEL BT-125-3
K994018 · Syncor Pharmaceuticals, Inc.
KXK · Source, Brachytherapy, Radionuclide · 234d
Cleared Jul 14, 2000
PHARMASEED, MODEL BT-103-3
K994016 · Syncor Pharmaceuticals, Inc.
KXK · Source, Brachytherapy, Radionuclide · 231d
Cleared Jul 13, 2000
FOCUS
K001729 · Instrumentarium Corp.
EHD · Unit, X-ray, Extraoral With Timer · 36d
Cleared Jul 13, 2000
POCKET ULTRASONIC PACHYMETER
K993674 · Quantel Medical
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 255d
Cleared Jul 13, 2000
BRAINSCAN
K994413 · Brainlab AG
MUJ · System, Planning, Radiation Therapy Treatment · 197d
Cleared Jul 10, 2000
PEDIATRIC REFERENCE DATA
K001812 · Lunar Corp.
KGI · Densitometer, Bone · 25d
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334 · Hitachi Medical Systems America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 70d
Cleared Jul 06, 2000
LUNAR REPORT GENERATOR II
K001756 · Lunar Corp.
KGI · Densitometer, Bone · 27d
Cleared Jul 06, 2000
MODIFICATION TO E-SCAN
K001894 · Biosound Esaote, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 15d
Cleared Jun 30, 2000
VSCORE WITH EKG SIGNAL GATING
K001682 · Vital Images, Inc.
JAK · System, X-ray, Tomography, Computed · 29d
Cleared Jun 29, 2000
NICOLET EME LEGEND TC22
K993939 · Nicolet Biomedical
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 223d
Cleared Jun 28, 2000
XPLAN 2.1
K001700 · Radionics, Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 23d
Cleared Jun 27, 2000
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · Shimadzu Corp.
IZL · System, X-ray, Mobile · 42d
Cleared Jun 23, 2000
VARIS 1.4G
K001643 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 24d
Cleared Jun 22, 2000
ULTRASIM CT SYSTEM
K001088 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 79d
Cleared Jun 22, 2000
ORTHOCEPH OC100 D
K001439 · Instrumentarium Corp.
MUH · System, X-ray, Extraoral Source, Digital · 45d
Cleared Jun 22, 2000
NOVAC7
K990209 · Hitesys S.P.A.
IYE · Accelerator, Linear, Medical · 518d

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All categories 12797 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 684 IYE Accelerator, Linear, Medical 584 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