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
12849 Radiology devices
9876–9900 of 12849
Cleared Dec 04, 1997
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
K973206 · Sterling Diagnostic Imaging, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 100d
Cleared Dec 04, 1997
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411 · General Scanning, Inc.
LMA · Digitizer, Image, Radiological · 86d
Cleared Dec 02, 1997
ACCUDEXA BONE DENSITOMETER
K971735 · Schick Technologies, Inc.
KGI · Densitometer, Bone · 204d
Cleared Dec 02, 1997
THERAPAX DXT 300 MODEL HF-300
K973315 · Pantak, Inc.
JAD · System, Therapeutic, X-ray · 90d
Cleared Dec 02, 1997
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K973463 · O Tech, Inc.
LMB · Device, Digital Image Storage, Radiological · 81d
Cleared Nov 26, 1997
DICOM 3.0 SOFTWARE VERSION 2.0
K973239 · Adac Laboratories
LMD · System, Digital Image Communications, Radiological · 90d
Cleared Nov 26, 1997
TRANSDUCER POSITIONER
K973622 · Protek Medical Products, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 64d
Cleared Nov 25, 1997
IMAGE FUSION AND REVIEW SYSTEM
K973233 · Adac Laboratories
KPS · System, Tomography, Computed, Emission · 89d
Cleared Nov 25, 1997
LEG'MAP OPTION
K973270 · Ge Medical Systems, Inc.
IZI · System, X-ray, Angiographic · 84d
Cleared Nov 25, 1997
IMATION MODEL 9410 NETWORK INTERFACE
K973303 · Imation Corp.
LMD · System, Digital Image Communications, Radiological · 83d
Cleared Nov 25, 1997
ID. STORE (RELEASE 2.0)
K973413 · I.S.G. Technologies, Inc.
LMB · Device, Digital Image Storage, Radiological · 77d
Cleared Nov 21, 1997
DIGITAL ADD-ON BUCKY
K970136 · Swissray Teleray AG
KPR · System, X-ray, Stationary · 310d
Cleared Nov 21, 1997
SMARTVIEW OPTIONS FOR HISPEED CT/I
K973168 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 88d
Cleared Nov 21, 1997
PROSTATE SEEDING NEEDLE
K973184 · Promex, Inc.
IWJ · System, Applicator, Radionuclide, Manual · 88d
Cleared Nov 21, 1997
ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100
K973642 · Instrumentarium Imaging, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 58d
Cleared Nov 21, 1997
GIOTTO HT
K973856 · Sitco, Inc.
IZH · System, X-ray, Mammographic · 43d
Cleared Nov 21, 1997
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE
K973889 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 38d
Cleared Nov 20, 1997
MACOM
K973148 · A.Stein - Regulatory Affairs Consulting
LLZ · System, Image Processing, Radiological · 90d
Cleared Nov 19, 1997
MEDIMAGE
K972215 · Vepro - Computersysteme GmbH
LLZ · System, Image Processing, Radiological · 159d
Cleared Nov 19, 1997
IMATION SE-204 LASER IMAGER
K972822 · Imation Enterprises Corp.
LMC · Camera, Multi Format, Radiological · 112d
Cleared Nov 18, 1997
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
K972517 · Lunar Corp.
KGI · Densitometer, Bone · 134d
Cleared Nov 14, 1997
SENSOR PAD
K973450 · Inventive Products, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 64d
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

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All categories 12849 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 587 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 314 KPR System, X-ray, Stationary 296 MUJ System, Planning, Radiation Therapy Treatment 238 MUH System, X-ray, Extraoral Source, Digital 193