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
12766 Radiology devices
8401–8425 of 12766
Cleared Mar 26, 2004
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
K040719 · Aloka Co., Ltd.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 7d
Cleared Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
K040541 · Varian Medical Systems, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 20d
Cleared Mar 22, 2004
SOMATOM PROJECT P30L
K040577 · Siemens Medical Systems, Inc.
JAK · System, X-ray, Tomography, Computed · 18d
Cleared Mar 17, 2004
CAAS II RVA
K033920 · Pie Medical Imaging BV
LLZ · System, Image Processing, Radiological · 90d
Cleared Mar 17, 2004
NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040039 · Barco N.V.
LLZ · System, Image Processing, Radiological · 68d
Cleared Mar 09, 2004
SIREMOBIL ISO-C 3D
K040347 · Siemens Medical Systems, Inc.
OXO · Image-intensified Fluoroscopic X-ray System, Mobile · 26d
Cleared Mar 09, 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 26d
Cleared Mar 09, 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 26d
Cleared Mar 09, 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
K040502 · Siemens Medical Solutions USA, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 11d
Cleared Mar 05, 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 28d
Cleared Mar 02, 2004
CT-MASS
K033774 · Medis Medical Imaging Systems BV
JAK · System, X-ray, Tomography, Computed · 90d
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372 · Ge Medical Systems, LLC
JAK · System, X-ray, Tomography, Computed · 13d
Cleared Feb 27, 2004
ON-BOARD IMAGER DEVICE
K040192 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 30d
Cleared Feb 27, 2004
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM
K040409 · Larsen & Toubro Limited
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 9d
Cleared Feb 26, 2004
3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
K032555 · Totoku Electric Co., Ltd.
LLZ · System, Image Processing, Radiological · 191d
Cleared Feb 25, 2004
AUTOQUANT PLUS
K040326 · Adac Laboratories
KPS · System, Tomography, Computed, Emission · 15d
Cleared Feb 24, 2004
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
K033650 · Siemens Medical Solutions USA, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 96d
Cleared Feb 24, 2004
VITREA2 VERSION 3.5
K040305 · Vital Images, Inc.
LLZ · System, Image Processing, Radiological · 15d
Cleared Feb 20, 2004
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
K032443 · Shimadzu Corp.
IZI · System, X-ray, Angiographic · 196d
Cleared Feb 20, 2004
COLOR LCD DISPLAY, MODEL RADIFORCE R22
K033466 · Eizo Nanao Corporation
LLZ · System, Image Processing, Radiological · 112d
Cleared Feb 20, 2004
BRAIN PERFUSION OPTION
K033677 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 88d
Cleared Feb 20, 2004
TROPHYPAN AND TROPHYPAN C
K033690 · Trophy Radiologie
EHD · Unit, X-ray, Extraoral With Timer · 88d
Cleared Feb 20, 2004
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
K033821 · Eastman Kodak Company
LMC · Camera, Multi Format, Radiological · 73d
Cleared Feb 19, 2004
INTEGRIS 3D-RA, RELEASE 4.2
K040254 · Philips Medical Systems North America Co.
LLZ · System, Image Processing, Radiological · 15d
Cleared Feb 12, 2004
SIREMOBILE C06
K040066 · Siemens Medical Solutions USA, Inc.
OXO · Image-intensified Fluoroscopic X-ray System, Mobile · 30d

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All categories 12766 LLZ System, Image Processing, Radiological 2026 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1122 LNH System, Nuclear Magnetic Resonance Imaging 996 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 681 IYE Accelerator, Linear, Medical 581 MOS Coil, Magnetic Resonance, Specialty 454 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 KPS System, Tomography, Computed, Emission 386 ITX Transducer, Ultrasonic, Diagnostic 345 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 312 KPR System, X-ray, Stationary 290 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 191