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
12655 Radiology devices
6776–6800 of 12655
Cleared Sep 30, 2008
CIVASTRING PD-103
K082159 · Civatech Oncology, Inc.
KXK · Source, Brachytherapy, Radionuclide · 61d
Cleared Sep 30, 2008
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
K082656 · Fukuda Denshi USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 18d
Cleared Sep 26, 2008
UNISYN IMAGE FUSION, VERSION 1.0
K081987 · Convergent Imaging Solutions
LLZ · System, Image Processing, Radiological · 74d
Cleared Sep 26, 2008
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
K082167 · Digimed Corporation
EHD · Unit, X-ray, Extraoral With Timer · 57d
Cleared Sep 26, 2008
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · General Electric Co.
KGI · Densitometer, Bone · 44d
Cleared Sep 25, 2008
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K081386 · Esaote, S.P.A.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 129d
Cleared Sep 25, 2008
AW SERVER
K081985 · Ge Medical Systems, LLC
LLZ · System, Image Processing, Radiological · 73d
Cleared Sep 25, 2008
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K082636 · Quality Electrodynamics
MOS · Coil, Magnetic Resonance, Specialty · 15d
Cleared Sep 23, 2008
ULTRAEXTEND USWS-900A
K082596 · Toshiba America Medical Systems, In.C
LLZ · System, Image Processing, Radiological · 15d
Cleared Sep 22, 2008
PLANISIGHT LINASYS
K082228 · Pathfinder Therapeutics, Inc.
LLZ · System, Image Processing, Radiological · 46d
Cleared Sep 19, 2008
RAYPAX SYSTEM
K081948 · Raypax, Inc.
LLZ · System, Image Processing, Radiological · 73d
Cleared Sep 17, 2008
SPY ANALYSIS TOOLKIT, MODEL SA9000
K081792 · Novadaq Technologies, Inc.
LLZ · System, Image Processing, Radiological · 84d
Cleared Sep 16, 2008
MODIFICATION TO AURORA MRI SYSTEM
K073425 · Aurora Imaging Technology, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 288d
Cleared Sep 16, 2008
INREACH PLANNING LAPTOP
K082386 · Superdimension, Ltd.
LLZ · System, Image Processing, Radiological · 28d
Cleared Sep 12, 2008
21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
K081945 · Totoku Electric Co., Ltd.
LLZ · System, Image Processing, Radiological · 66d
Cleared Sep 12, 2008
CONTURA LUMEN MARKER
K082264 · Senorx, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 32d
Cleared Sep 12, 2008
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM
K082368 · Digirad Corp.
KPS · System, Tomography, Computed, Emission · 25d
Cleared Sep 12, 2008
QUANTRA
K082483 · Hologic, Inc.
LLZ · System, Image Processing, Radiological · 15d
Cleared Sep 12, 2008
DRAD3000E/RADREX-I
K082494 · Toshiba America Medical Systems, In.C
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 14d
Cleared Sep 10, 2008
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER
K081557 · Jddb Manufacturing, Inc.
IXA · Cassette, Radiographic Film · 99d
Cleared Sep 10, 2008
VISUALASE THERMAL THERAPY SYSTEM
K081656 · Biotex, Inc.
LLZ · System, Image Processing, Radiological · 90d
Cleared Sep 09, 2008
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
K073328 · Paieon, Inc.
IZI · System, X-ray, Angiographic · 287d
Cleared Sep 09, 2008
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
K081919 · Fukuda Denshi Co., Ltd.
ITX · Transducer, Ultrasonic, Diagnostic · 64d
Cleared Sep 09, 2008
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
K082485 · Neusoft Medical Systems Co., Ltd.
LNH · System, Nuclear Magnetic Resonance Imaging · 12d
Cleared Sep 09, 2008
PACSMATE MMD-3213M MONITOR
K082496 · Iei Technology Corp.
LLZ · System, Image Processing, Radiological · 11d

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 12655 LLZ System, Image Processing, Radiological 2006 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1116 LNH System, Nuclear Magnetic Resonance Imaging 991 JAK System, X-ray, Tomography, Computed 743 IYO System, Imaging, Pulsed Echo, Ultrasonic 673 IYE Accelerator, Linear, Medical 572 MOS Coil, Magnetic Resonance, Specialty 448 MQB Solid State X-ray Imager (flat Panel/digital Imager) 407 KPS System, Tomography, Computed, Emission 384 ITX Transducer, Ultrasonic, Diagnostic 341 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 310 KPR System, X-ray, Stationary 287 MUJ System, Planning, Radiation Therapy Treatment 228 JAA System, X-ray, Fluoroscopic, Image-intensified 190