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
12945 Radiology devices
11951–11975 of 12945
Cleared Oct 31, 1988
SIEMENS PACS/I-A
K880690 · Siemens Gammasonics, Inc.
IZI · System, X-ray, Angiographic · 252d
Cleared Oct 21, 1988
GENESIS 180
K883863 · Fischer Imaging Corp.
IXR · Table, Radiographic, Tilting · 38d
Cleared Oct 21, 1988
MICRO-X 100CP
K884134 · Fischer Imaging Corp.
IZO · Generator, High-voltage, X-ray, Diagnostic · 21d
Cleared Oct 20, 1988
TANGENT II
K883974 · Fischer Imaging Corp.
IZZ · Table, Radiographic, Non-tilting, Powered · 30d
Cleared Oct 19, 1988
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
K881305 · Toshiba Medical Systems
JAK · System, X-ray, Tomography, Computed · 205d
Cleared Oct 19, 1988
VISTA MR 2055 HP SYSTEM
K883482 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 64d
Cleared Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
K883519 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 62d
Cleared Oct 19, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
K883649 · Instrumentarium Corp.
LNH · System, Nuclear Magnetic Resonance Imaging · 51d
Cleared Oct 13, 1988
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
K883092 · Bennett X-Ray Corp.
IZL · System, X-ray, Mobile · 83d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737 · Resonex, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 42d
Cleared Oct 12, 1988
DIGITRON STENOSIS PROTOCOL
K881481 · Siemens Gammasonics, Inc.
LLZ · System, Image Processing, Radiological · 187d
Cleared Oct 12, 1988
100-01778-52 ULTRASOUND SYSTEM
K882478 · Diasonics, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 118d
Cleared Oct 11, 1988
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 125d
Cleared Oct 11, 1988
SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25
K883264 · Philips Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 70d
Cleared Oct 07, 1988
DIASONICS MT/P IMAGING SYSTEM
K883516 · Diasonics, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 52d
Cleared Oct 07, 1988
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST
K883520 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 50d
Cleared Oct 07, 1988
TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER
K883546 · Advanced Technology Laboratories, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 49d
Cleared Oct 05, 1988
PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR
K883965 · Teknar, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d
Cleared Sep 30, 1988
MODIFIED SL-SERIES LINEAR ACCELERATORS
K883067 · Philips Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 116d
Cleared Sep 29, 1988
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280 · Hologic, Inc.
KGI · Densitometer, Bone · 57d
Cleared Sep 27, 1988
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360 · Hologic, Inc.
KGI · Densitometer, Bone · 49d
Cleared Sep 22, 1988
SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
K882231 · Philips Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 118d
Cleared Sep 22, 1988
VISTA MR 2055 HP SYSTEM
K883378 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 44d
Cleared Sep 21, 1988
MEDACORD PVL, PERSONAL VASCULAR LABORATORY
K882018 · Medasonics, Inc.
JAF · Monitor, Ultrasonic, Nonfetal · 131d
Cleared Sep 19, 1988
VARIAN CLINAC 1800S
K882326 · Varian Assoc., Inc.
IYE · Accelerator, Linear, Medical · 105d

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 12945 LLZ System, Image Processing, Radiological 2063 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1138 LNH System, Nuclear Magnetic Resonance Imaging 1002 JAK System, X-ray, Tomography, Computed 754 IYO System, Imaging, Pulsed Echo, Ultrasonic 691 IYE Accelerator, Linear, Medical 590 MOS Coil, Magnetic Resonance, Specialty 461 MQB Solid State X-ray Imager (flat Panel/digital Imager) 418 KPS System, Tomography, Computed, Emission 391 ITX Transducer, Ultrasonic, Diagnostic 348 QIH Automated Radiological Image Processing Software 329 OWB Interventional Fluoroscopic X-ray System 315 KPR System, X-ray, Stationary 297 MUJ System, Planning, Radiation Therapy Treatment 239 MUH System, X-ray, Extraoral Source, Digital 194