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

15507
Total
15488
Cleared
146d
Avg (2y)
1976
Since
4687 Radiology devices
3901–3925 of 4687
Cleared Sep 29, 2005
SITE-RITE 5 ULTRASOUND SYSTEM
K052517 · C.R. Bard, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 15d
Cleared Sep 22, 2005
ACUSON SEQUOIA ULTRASOUND SYSTEM
K052410 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 20d
Cleared Sep 22, 2005
SIMTEC IM-MAXX 2 OPTION
K052315 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 28d
Cleared Sep 21, 2005
GE LOGIQ 7 ULTRASOUND BT05
K052441 · General Electric Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 15d
Cleared Sep 08, 2005
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
K052305 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 15d
Cleared Sep 07, 2005
AIDA COMPACT II SYSTEM
K052159 · KARL STORZ Endoscopy-America, Inc.
LLZ · System, Image Processing, Radiological · 29d
Cleared Aug 17, 2005
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER
K052021 · Siemens Medical Solutions USA, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 22d
Cleared Jul 01, 2005
SMITH & NEPHEW CDS SYSTEM
K051136 · Smith & Nephew, Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 58d
Cleared Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · Eastman Kodak Company
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 15d
Cleared Jun 01, 2005
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
K051258 · Eastman Kodak Company
KPR · System, X-ray, Stationary · 16d
Cleared Jun 01, 2005
ARCADIS AVANTIC
K051133 · Siemens Medical Solutions USA, Inc.
OXO · Image-intensified Fluoroscopic X-ray System, Mobile · 29d
Cleared May 23, 2005
GEMINI GXL
K051170 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 17d
Cleared May 23, 2005
GE VIEWPOINT
K050943 · General Electric Co.
LLZ · System, Image Processing, Radiological · 39d
Cleared May 20, 2005
ATLANTIS PV
K050684 · Boston Scientific Corp
DQO · Catheter, Intravascular, Diagnostic · 64d
Cleared May 13, 2005
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K051139 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 9d
Cleared Apr 18, 2005
SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
K050724 · C.R. Bard, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 28d
Cleared Apr 08, 2005
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
K050704 · General Electric Co.
KPR · System, X-ray, Stationary · 21d
Cleared Mar 18, 2005
550 TXT TREATMENT TABLE
K050422 · Siemens Medical Solutions USA, Inc.
JAI · Couch, Radiation Therapy, Powered · 28d
Cleared Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
K050200 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 31d
Cleared Feb 15, 2005
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K050240 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 13d
Cleared Feb 02, 2005
GE LOGIQ TWIN
K050126 · General Electric Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 14d
Cleared Feb 02, 2005
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc.
KXK · Source, Brachytherapy, Radionuclide · 71d
Cleared Jan 13, 2005
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K050034 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 6d
Cleared Jan 06, 2005
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 80d
Cleared Dec 23, 2004
SOMATOM RESPIRATORY GATING
K043086 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 45d

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All categories 4687 LLZ System, Image Processing, Radiological 718 IYN System, Imaging, Pulsed Doppler, Ultrasonic 532 LNH System, Nuclear Magnetic Resonance Imaging 396 JAK System, X-ray, Tomography, Computed 341 QIH Automated Radiological Image Processing Software 296 OWB Interventional Fluoroscopic X-ray System 177 IYO System, Imaging, Pulsed Echo, Ultrasonic 168 IYE Accelerator, Linear, Medical 164 KPS System, Tomography, Computed, Emission 148 MQB Solid State X-ray Imager (flat Panel/digital Imager) 141 KPR System, X-ray, Stationary 103 MUJ System, Planning, Radiation Therapy Treatment 91 IZL System, X-ray, Mobile 89 QAS Radiological Computer-assisted Triage And Notification Software 85 MOS Coil, Magnetic Resonance, Specialty 77