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
12852 Radiology devices
9901–9925 of 12852
Cleared Nov 13, 1997
IMAGING JET SYSTEM
K970782 · General Robotic Devices, Inc.
JAB · System, X-ray, Fluoroscopic, Non-image-intensified · 254d
Cleared Nov 13, 1997
SNT LINAC ACCESSORIES
K971893 · Surgical Navigation Technologies, Inc.
IYE · Accelerator, Linear, Medical · 175d
Cleared Nov 13, 1997
REALVIEW TELEMEDICINE SYSTEM
K973065 · Vcom Systems, Inc.
LLZ · System, Image Processing, Radiological · 87d
Cleared Nov 12, 1997
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K973131 · Siemens Medical Solutions USA, Inc.
LMD · System, Digital Image Communications, Radiological · 83d
Cleared Nov 10, 1997
RAVEN DRY PRINTER
K972660 · Sterling Diagnostic Imaging, Inc.
LMC · Camera, Multi Format, Radiological · 117d
Cleared Nov 10, 1997
REALTIME 3D DIAGNOSTIC WORKSTATION
K973010 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 89d
Cleared Nov 10, 1997
MAMMOTEST ADAPTER DRIVER
K973400 · Fischer Imaging Corp.
IZH · System, X-ray, Mammographic · 62d
Cleared Nov 10, 1997
KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
K973476 · Eastman Kodak Company
EHD · Unit, X-ray, Extraoral With Timer · 56d
Cleared Nov 10, 1997
PHILIPS INTEGRIS V5000 AND BV5000
K973482 · Philips Medical Systems North America, Inc.
IZI · System, X-ray, Angiographic · 56d
Cleared Nov 10, 1997
PLANMED CYTOGUIDE
K973493 · Planmed OY
IZH · System, X-ray, Mammographic · 56d
Cleared Nov 10, 1997
SIREMOBIL CO2
K973598 · Siemens Medical Solutions USA, Inc.
OXO · Image-intensified Fluoroscopic X-ray System, Mobile · 49d
Cleared Nov 10, 1997
INFLATABLE POSITIONING CUSHIONS
K973915 · Kci New Technologies, Inc.
IZH · System, X-ray, Mammographic · 27d
Cleared Nov 05, 1997
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · Acuson Corp.
ITX · Transducer, Ultrasonic, Diagnostic · 79d
Cleared Nov 05, 1997
DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)
K973081 · Howtek, Inc.
LLZ · System, Image Processing, Radiological · 79d
Cleared Nov 04, 1997
CONTROL SYRINGE
K972655 · Medical Specialties Intl., Inc.
IZI · System, X-ray, Angiographic · 112d
Cleared Nov 04, 1997
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
K972903 · Imatron, Inc.
JAK · System, X-ray, Tomography, Computed · 90d
Cleared Oct 31, 1997
APOLLO
K972882 · Norland Corp.
KGI · Densitometer, Bone · 87d
Cleared Oct 28, 1997
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K972271 · Ml Strategies, Inc.
KXK · Source, Brachytherapy, Radionuclide · 132d
Cleared Oct 28, 1997
XPLAN-1
K972905 · Radionics Software Applications, Inc.
IYE · Accelerator, Linear, Medical · 83d
Cleared Oct 28, 1997
HELIOS LASER IMAGER 1417
K973028 · Sterling Diagnostic Imaging, Inc.
LMC · Camera, Multi Format, Radiological · 75d
Cleared Oct 28, 1997
MEDSTATION
K973090 · Program S.R.L.
LMD · System, Digital Image Communications, Radiological · 71d
Cleared Oct 28, 1997
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
K973422 · Dejarnette Research Systems
LMC · Camera, Multi Format, Radiological · 48d
Cleared Oct 27, 1997
BRAINSCAN CONFORMAL RT MODULE
K971367 · Brainlab AG
IYE · Accelerator, Linear, Medical · 196d
Cleared Oct 27, 1997
VOX/BASE FOR WINDOWS
K972933 · J-Mac System, Inc.
LLZ · System, Image Processing, Radiological · 80d
Cleared Oct 23, 1997
MCD-AC
K971980 · Adac Laboratories
KPS · System, Tomography, Computed, Emission · 147d

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All categories 12852 LLZ System, Image Processing, Radiological 2039 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1133 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 749 IYO System, Imaging, Pulsed Echo, Ultrasonic 687 IYE Accelerator, Linear, Medical 588 MOS Coil, Magnetic Resonance, Specialty 459 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 315 KPR System, X-ray, Stationary 296 MUJ System, Planning, Radiation Therapy Treatment 238 MUH System, X-ray, Extraoral Source, Digital 193