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
12832 Radiology devices
9226–9250 of 12832
Cleared Dec 15, 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · Acuson Corp.
DQO · Catheter, Intravascular, Diagnostic · 131d
Cleared Dec 15, 1999
SYSTEM 2100
K993530 · Math Solutions, LLC
LLZ · System, Image Processing, Radiological · 58d
Cleared Dec 15, 1999
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)
K993532 · Impax Technology, Inc.
LLZ · System, Image Processing, Radiological · 57d
Cleared Dec 15, 1999
CONFORMAX MMLC VR1
K993594 · Radionics, Inc.
IYE · Accelerator, Linear, Medical · 51d
Cleared Dec 15, 1999
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K993597 · Vidar Systems Corp.
LMA · Digitizer, Image, Radiological · 51d
Cleared Dec 08, 1999
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K993766 · Helax AB
MUJ · System, Planning, Radiation Therapy Treatment · 30d
Cleared Dec 07, 1999
PHILIPS EASYVISION WORKSTATION
K990329 · Philips Medical Systems North America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 308d
Cleared Dec 03, 1999
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
K992992 · Toshiba America Medical Systems, In.C
KPS · System, Tomography, Computed, Emission · 87d
Cleared Dec 03, 1999
OBC-300 BREAST ARRAY COIL
K993776 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 25d
Cleared Dec 03, 1999
QWH-300 WRIST ARRAY COIL
K993819 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 23d
Cleared Nov 26, 1999
PRIMUS
K993425 · Siemens Medical Solutions USA, Inc.
IYE · Accelerator, Linear, Medical · 45d
Cleared Nov 26, 1999
KAC-300 KNEE ARRAY COIL
K993719 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 23d
Cleared Nov 26, 1999
MAMEX
K993740 · Medical Systems Group
IZH · System, X-ray, Mammographic · 22d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
K993763 · Medis Medical Imaging Systems BV
IZI · System, X-ray, Angiographic · 18d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
K993765 · Medis Medical Imaging Systems BV
IZI · System, X-ray, Angiographic · 18d
Cleared Nov 26, 1999
QSC-300 SHOULDER ARRAY COILS
K993780 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 18d
Cleared Nov 24, 1999
CT PERFUSION OPTION
K993791 · Ge Medical Systems, Inc.
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Nov 24, 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792 · Ge Medical Systems, Inc.
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Nov 23, 1999
AX WORKSTATION DR-VIEWER SOFTWARE OPTION
K992925 · Siemens Corp.
LLZ · System, Image Processing, Radiological · 85d
Cleared Nov 22, 1999
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · Norland Medical Systems, Inc.
KGI · Densitometer, Bone · 152d
Cleared Nov 18, 1999
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
K990475 · Kps & Assoc., Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 275d
Cleared Nov 12, 1999
LEGEND CRF FLUORO AND RAD SYSTEM
K993665 · Ge Medical Systems, Inc.
KPR · System, X-ray, Stationary · 14d
Cleared Nov 10, 1999
TERATECH, MODEL 2000 IMAGING IMAGING
K992505 · Teratech Corp.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 106d
Cleared Nov 10, 1999
E.CAM COMPUTER
K992731 · Siemens Medical Solutions USA, Inc.
KPS · System, Tomography, Computed, Emission · 89d
Cleared Nov 10, 1999
SITE-RITE 3 ULTRASOUND SYSTEM
K993624 · Dymax Corp
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d

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All categories 12832 LLZ System, Image Processing, Radiological 2037 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1128 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