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
12868 Radiology devices
10151–10175 of 12868
Cleared Mar 19, 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902 · Medical Marketing Intl., Inc.
IZH · System, X-ray, Mammographic · 579d
Cleared Mar 19, 1997
PHILIPS SONO DIAGNOST 800
K963706 · Hewlett-Packard Co.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 184d
Cleared Mar 17, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE
K963315 · Vingmed Sound, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 207d
Cleared Mar 17, 1997
RADX SYSTEM
K965203 · Electro Medical Systems, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 81d
Cleared Mar 17, 1997
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
K970034 · Hewlett-Packard Co.
ITX · Transducer, Ultrasonic, Diagnostic · 73d
Cleared Mar 17, 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064 · Autocyt Group, Inc.
LMD · System, Digital Image Communications, Radiological · 69d
Cleared Mar 12, 1997
CONTRAST MEDIA SET
K955179 · B.Braun Medical, Inc.
IZI · System, X-ray, Angiographic · 485d
Cleared Mar 12, 1997
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K965161 · Sectra-Imtec AB
LMD · System, Digital Image Communications, Radiological · 79d
Cleared Mar 12, 1997
TARGOGRID
K970037 · Daum GmbH
LNH · System, Nuclear Magnetic Resonance Imaging · 65d
Cleared Mar 11, 1997
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
K963273 · Smv America
KPS · System, Tomography, Computed, Emission · 203d
Cleared Mar 11, 1997
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
K965004 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 85d
Cleared Mar 11, 1997
SERIES 7600 MOBILE DIGITAL C-ARM
K970063 · Ge Dec Medical Systems
OWB · Interventional Fluoroscopic X-ray System · 63d
Cleared Mar 11, 1997
DIFFUSER PANEL
K970240 · Focused Viewer, Inc.
IXC · Illuminator, Radiographic-film · 48d
Cleared Mar 10, 1997
PVK-720ST ENDOCAVITARY TRANSDUCER
K964865 · Toshiba America Medical Systems, In.C
ITX · Transducer, Ultrasonic, Diagnostic · 96d
Cleared Mar 10, 1997
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS
K964910 · Alpha-Omega Services, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 91d
Cleared Mar 06, 1997
ANATOM 2000
K964890 · Analogic Corp.
JAK · System, X-ray, Tomography, Computed · 90d
Cleared Mar 04, 1997
MD-1835
K964806 · Fischer Imaging Corp.
IXL · Device, Spot-film · 95d
Cleared Mar 04, 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · Toshiba America Medical Systems, In.C
ITX · Transducer, Ultrasonic, Diagnostic · 57d
Cleared Feb 28, 1997
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
K964820 · Us Asia Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 88d
Cleared Feb 28, 1997
ISOCAM II (DUAL HEAD GAMMA CAMERA)
K964834 · Park Medical Systems, Inc.
KPS · System, Tomography, Computed, Emission · 88d
Cleared Feb 26, 1997
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 181d
Cleared Feb 26, 1997
VIPOR UNIT
K964322 · Tilane Corp.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 120d
Cleared Feb 26, 1997
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
K964813 · Medical Advances, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 89d
Cleared Feb 26, 1997
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
K964990 · Hitachi Medical Systems America, Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 72d
Cleared Feb 26, 1997
PM 2002 CC PROLINE
K970263 · Planmeca Oy
EHD · Unit, X-ray, Extraoral With Timer · 34d

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All categories 12868 LLZ System, Image Processing, Radiological 2044 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1134 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 750 IYO System, Imaging, Pulsed Echo, Ultrasonic 689 IYE Accelerator, Linear, Medical 588 MOS Coil, Magnetic Resonance, Specialty 460 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