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

15668
Total
15649
Cleared
148d
Avg (2y)
1976
Since
12966 Radiology devices
12501–12525 of 12966
Cleared Apr 28, 1983
ULTRASOUND EQUIPMENT MODEL SDL-100A
K837084 · Elscint, Inc.
· 93d
Cleared Apr 28, 1983
TRANSPARENT X-RAY COMPENSATION FILTER
K837245 · Victoreen, Inc.
· 51d
Cleared Apr 22, 1983
X-RAY BEAM FILTER
K837334 · Eastman Kodak Company
· 23d
Cleared Apr 21, 1983
LASER PHOTOCOAGULATOR
K837306 · Hgm, Inc.
· 31d
Cleared Apr 21, 1983
EXOSCOPE LS-53
K837351 · Elscint, Inc.
· 17d
Cleared Apr 21, 1983
POWERED MOBILE BASE FOR 200MM AND 300MM SIZE DETECTORS
K837354 · General Electric Co.
· 17d
Cleared Apr 13, 1983
CEILEX LS-15/ALLMEC ARGOSTAT
K837352 · Elscint, Inc.
· 9d
Cleared Apr 13, 1983
FLOATEX LS-22
K837353 · Elscint, Inc.
· 9d
Cleared Apr 11, 1983
KODAK LANEX FAST SCREENS SO-470
K837201 · Eastman Kodak Company
· 45d
Cleared Apr 11, 1983
KODAK ORTHO C FILM SO-344
K837202 · Eastman Kodak Company
· 45d
Cleared Apr 04, 1983
BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM
K837063 · Biosound, Inc.
· 77d
Cleared Apr 04, 1983
BRITT SURGICAL PHOTOCOAGULATOR SYSTEM
K837200 · Britt Corp., Inc.
· 70d
Cleared Apr 01, 1983
AUTOFOCUS PROBE FOR USE WITH ULTRASOUND AUTOSECTOR SYSTEM
K837046 · Technicare Corp.
· 81d
Cleared Apr 01, 1983
EMINEX LS-8 SYSTEM
K837181 · Elscint, Inc.
· 44d
Cleared Mar 22, 1983
ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE
K837029 · American Electromedics Corp.
· 102d
Cleared Mar 22, 1983
BLUE GREEN FILTER SYSTEM TO MODEL 152 AND 150 LASER SYSTEM
K837151 · Britt Corp., Inc.
· 57d
Cleared Mar 22, 1983
STANDEX SYSTEM
K837178 · Elscint, Inc.
· 34d
Cleared Mar 17, 1983
ULTRASONIC ECHOSCOPE
K837171 · Ausonics Pty , Ltd.
· 29d
Cleared Mar 17, 1983
ARMEX LS-51
K837175 · Elscint, Inc.
· 29d
Cleared Mar 17, 1983
EXOR LS-24
K837176 · Elscint, Inc.
· 29d
Cleared Mar 17, 1983
CONTROLLEX LS-5
K837177 · Elscint, Inc.
· 29d
Cleared Mar 17, 1983
TAURUS LS THREE-PHASE GENERATORS
K837179 · Elscint, Inc.
· 29d
Cleared Mar 17, 1983
TREPHIX THREE PHSE GENERATORS AND EXONON SINGLE PHASE GENERATORS
K837180 · Elscint, Inc.
· 29d
Cleared Mar 17, 1983
TOMAX LS-20
K837182 · Elscint, Inc.
· 29d
Cleared Mar 17, 1983
HI-LO RADIOLOGICAL STRETCHER
K837183 · Elscint, Inc.
· 29d

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All categories 12966 LLZ System, Image Processing, Radiological 2065 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1140 LNH System, Nuclear Magnetic Resonance Imaging 1004 JAK System, X-ray, Tomography, Computed 756 IYO System, Imaging, Pulsed Echo, Ultrasonic 692 IYE Accelerator, Linear, Medical 592 MOS Coil, Magnetic Resonance, Specialty 461 MQB Solid State X-ray Imager (flat Panel/digital Imager) 418 KPS System, Tomography, Computed, Emission 393 ITX Transducer, Ultrasonic, Diagnostic 349 QIH Automated Radiological Image Processing Software 329 OWB Interventional Fluoroscopic X-ray System 316 KPR System, X-ray, Stationary 297 MUJ System, Planning, Radiation Therapy Treatment 241 MUH System, X-ray, Extraoral Source, Digital 194