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
12834 Radiology devices
9351–9375 of 12834
Cleared Aug 02, 1999
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
K991629 · Ge Medical Systems, Inc.
LLZ · System, Image Processing, Radiological · 83d
Cleared Aug 02, 1999
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
K991724 · Medical Advances, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 74d
Cleared Aug 02, 1999
OPART, MODEL MRT-600
K991740 · Toshiba America Mri, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 73d
Cleared Aug 02, 1999
SYNERGY SHOULDER COIL
K991765 · Philips Medical Systems North America, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 70d
Cleared Aug 02, 1999
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
K991805 · Acuson Corp.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 68d
Cleared Jul 30, 1999
TLC PEDIATRIC FRAME, MODEL TLC-SYS
K991523 · Radionics, Inc.
IYE · Accelerator, Linear, Medical · 88d
Cleared Jul 30, 1999
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991535 · Hitachi Medical Corp. of America
KPS · System, Tomography, Computed, Emission · 88d
Cleared Jul 30, 1999
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
K991546 · Aktina Medical Physics Corp.
IYE · Accelerator, Linear, Medical · 88d
Cleared Jul 30, 1999
ULTRASOUND SCANNER, MODEL TYPE 2101
K991937 · B & K Medical A/S
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 51d
Cleared Jul 30, 1999
MAMEX
K992037 · Del Medical Imaging Corp.
IZH · System, X-ray, Mammographic · 44d
Cleared Jul 26, 1999
VANTAGE 2.5
K991607 · Adac Laboratories
KPS · System, Tomography, Computed, Emission · 77d
Cleared Jul 20, 1999
AWARE PAD
K991469 · Aac Consulting Group, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 83d
Cleared Jul 19, 1999
MR SPECTROSCOPY PACKAGE
K991568 · Philips Medical Systems (Cleveland), Inc.
LNI · System, Nuclear Magnetic Resonance Spectroscopic · 75d
Cleared Jul 14, 1999
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
K983660 · Brainlab, Inc.
LHN · System, Radiation Therapy, Charged-particle, Medical · 268d
Cleared Jul 14, 1999
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K984563 · Accuray, Inc.
IWB · System, Radiation Therapy, Radionuclide · 203d
Cleared Jul 12, 1999
THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
K984639 · Medison America, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 193d
Cleared Jul 12, 1999
BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY
K991336 · Medical Instrumentation & Diagnostics Corp.(Midco)
IYE · Accelerator, Linear, Medical · 84d
Cleared Jul 12, 1999
GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
K992208 · Ge Medical Systems, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 12d
Cleared Jul 08, 1999
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7
K992155 · Medison America, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 13d
Cleared Jul 06, 1999
QUADRATURE WRIST COIL, MODEL 445PH-64
K991434 · Medical Advances, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 71d
Cleared Jul 06, 1999
IMMERGE IMAGE CORRELATION
K991468 · Surgical Navigation Technologies, Inc.
LLZ · System, Image Processing, Radiological · 70d
Cleared Jul 06, 1999
SAMSUNG RAYPAX SYSTEM
K991537 · Samsung Sds Co., Ltd.
LMD · System, Digital Image Communications, Radiological · 64d
Cleared Jul 02, 1999
MODIFICATION TO GAMMA GUIDANCE SYSTEM
K983768 · Radiation Monitoring Devices, Inc.
IZD · Probe, Uptake, Nuclear · 249d
Cleared Jul 02, 1999
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
K991626 · Analogic Corp.
LLZ · System, Image Processing, Radiological · 52d
Cleared Jun 30, 1999
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
K991282 · Seiko Instruments USA, Inc.
LMC · Camera, Multi Format, Radiological · 77d

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All categories 12834 LLZ System, Image Processing, Radiological 2037 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1129 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 749 IYO System, Imaging, Pulsed Echo, Ultrasonic 686 IYE Accelerator, Linear, Medical 586 MOS Coil, Magnetic Resonance, Specialty 458 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 314 KPR System, X-ray, Stationary 296 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 193