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
12736 Radiology devices
7851–7875 of 12736
Cleared Oct 18, 2005
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K052433 · Bioptics, Inc.
MWP · Cabinet, X-ray System · 42d
Cleared Oct 17, 2005
REFORMAT GATEWAY
K052284 · Infinitt Co., Ltd.
LLZ · System, Image Processing, Radiological · 56d
Cleared Oct 17, 2005
HDR IORT SHIELDED APPLICATOR
K052351 · Mick Radio-Nuclear Instruments, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 49d
Cleared Oct 17, 2005
DAR-8000F
K052500 · Shimadzu Medical Systems
IZI · System, X-ray, Angiographic · 34d
Cleared Oct 17, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
K052571 · Neurognostics, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 28d
Cleared Oct 17, 2005
MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
K052805 · Esaote, S.P.A.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 13d
Cleared Oct 12, 2005
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
K052497 · Invivo Corp.
MOS · Coil, Magnetic Resonance, Specialty · 30d
Cleared Oct 07, 2005
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
K052312 · Wide Corporation
LLZ · System, Image Processing, Radiological · 44d
Cleared Oct 07, 2005
AJEX 9015/135H PORTABLE X-RAY
K052341 · Jpi America, Inc.
IZL · System, X-ray, Mobile · 42d
Cleared Oct 07, 2005
1.5T 12 CHANNEL BODY ARRAY
K052584 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 17d
Cleared Oct 07, 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 14d
Cleared Oct 07, 2005
GEMINI RAPTOR
K052640 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 11d
Cleared Oct 05, 2005
ETIAM STAR PACS COMPONENTS
K052358 · Etiam, S.A.
LLZ · System, Image Processing, Radiological · 37d
Cleared Oct 04, 2005
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
K052164 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 56d
Cleared Oct 04, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K052430 · Digirad Corp.
KPS · System, Tomography, Computed, Emission · 28d
Cleared Oct 04, 2005
3T HD BREAST ARRAY
K052585 · Usa Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 14d
Cleared Sep 30, 2005
IPLAN RT FIBERTRACKING
K052220 · Brainlab AG
IYE · Accelerator, Linear, Medical · 46d
Cleared Sep 30, 2005
COLOR CORONIS 2MP-21 AND MFCD 2321
K052352 · Barcoview
LLZ · System, Image Processing, Radiological · 32d
Cleared Sep 30, 2005
E-2320 PA S
K052529 · Barcoview
LLZ · System, Image Processing, Radiological · 16d
Cleared Sep 29, 2005
SITE-RITE 5 ULTRASOUND SYSTEM
K052517 · C.R. Bard, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 15d
Cleared Sep 28, 2005
MFCD 1219, MFCD 1219 TS
K052478 · Barcoview
LLZ · System, Image Processing, Radiological · 19d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172 · Hitachi Medical Systems America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 49d
Cleared Sep 27, 2005
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
K052422 · Flow X-Ray Corp.
EAP · Unit, X-ray, Intraoral · 25d
Cleared Sep 27, 2005
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K052434 · GE Medical Systems
KPS · System, Tomography, Computed, Emission · 21d
Cleared Sep 27, 2005
PORTAL GRAVITY SYSTEM
K052579 · Portal, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 7d

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 12736 LLZ System, Image Processing, Radiological 2021 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1118 LNH System, Nuclear Magnetic Resonance Imaging 995 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 679 IYE Accelerator, Linear, Medical 579 MOS Coil, Magnetic Resonance, Specialty 453 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 KPS System, Tomography, Computed, Emission 385 ITX Transducer, Ultrasonic, Diagnostic 344 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 312 KPR System, X-ray, Stationary 288 MUJ System, Planning, Radiation Therapy Treatment 234 JAA System, X-ray, Fluoroscopic, Image-intensified 190