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
12885 Radiology devices
10801–10825 of 12885
Cleared Nov 14, 1994
SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.
K931021 · Shimadzu Medical Systems
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 623d
Cleared Nov 07, 1994
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
K940541 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 273d
Cleared Nov 07, 1994
GEMNET
K943355 · GE Medical Systems
IZI · System, X-ray, Angiographic · 118d
Cleared Oct 26, 1994
ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)
K930964 · Acuson Corp.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 609d
Cleared Oct 21, 1994
ACUSON MODEL 2001
K934915 · Acuson Corp.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 371d
Cleared Oct 21, 1994
R AND D BATTERIES
K935427 · R & D Batteries, Inc.
JAF · Monitor, Ultrasonic, Nonfetal · 345d
Cleared Oct 21, 1994
ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION
K941652 · Aloka Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 199d
Cleared Oct 21, 1994
PHILIPS TOMOSCAN SR5000
K944326 · Philips Medical Systems North America, Inc.
JAK · System, X-ray, Tomography, Computed · 53d
Cleared Oct 20, 1994
SSA-380A
K933743 · Toshiba America Medical Systems, In.C
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 443d
Cleared Oct 14, 1994
MRT-150A
K943021 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 112d
Cleared Oct 13, 1994
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
K942731 · Shimadzu Corp.
IZO · Generator, High-voltage, X-ray, Diagnostic · 147d
Cleared Oct 11, 1994
PEGASUS
K935009 · Advanced Technology Laboratories, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 356d
Cleared Oct 11, 1994
PHILIPS TOMOSCAN SR 4000
K936272 · Philips Medical Systems North America, Inc.
JAK · System, X-ray, Tomography, Computed · 285d
Cleared Oct 04, 1994
PINNACLE 3
K926008 · Adac Laboratories
IYE · Accelerator, Linear, Medical · 676d
Cleared Oct 03, 1994
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
K933916 · Ausonics Pty , Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 418d
Cleared Sep 30, 1994
HP 77010CF
K943634 · Hewlett-Packard Co.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 66d
Cleared Sep 23, 1994
VARIAN RMS-2000, RELEASE 2.5
K930513 · Varian Assoc., Inc.
IYE · Accelerator, Linear, Medical · 599d
Cleared Sep 23, 1994
VARIAN ORIGAMI, VERSION 1.0
K932501 · Varian Assoc., Inc.
IYE · Accelerator, Linear, Medical · 486d
Cleared Sep 23, 1994
PATLAK & FDG AUTORADIOGRAPHIC
K936001 · GE Medical Systems
KPS · System, Tomography, Computed, Emission · 282d
Cleared Sep 23, 1994
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER
K942146 · Siemens Medical Solutions USA, Inc.
KPS · System, Tomography, Computed, Emission · 143d
Cleared Sep 23, 1994
QUAD PELVIS COIL
K943321 · Hitachi Medical Systems America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 74d
Cleared Sep 23, 1994
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
K943805 · General Electric Co.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 50d
Cleared Sep 22, 1994
HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION
K934041 · Hewlett-Packard Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 399d
Cleared Sep 20, 1994
SOMATOM PROJECT 059
K941546 · Siemens Corp.
JAK · System, X-ray, Tomography, Computed · 173d
Cleared Sep 16, 1994
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
K934987 · Elscint, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 333d

Looking for a specific radiology device? Search by device name, K-number or manufacturer.

Search all Radiology 510(k) devices

Filter by Product Code

All categories 12885 LLZ System, Image Processing, Radiological 2048 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1134 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 751 IYO System, Imaging, Pulsed Echo, Ultrasonic 690 IYE Accelerator, Linear, Medical 589 MOS Coil, Magnetic Resonance, Specialty 460 MQB Solid State X-ray Imager (flat Panel/digital Imager) 417 KPS System, Tomography, Computed, Emission 388 ITX Transducer, Ultrasonic, Diagnostic 347 QIH Automated Radiological Image Processing Software 321 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