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
4719 Radiology devices
3926–3950 of 4719
Cleared Dec 15, 2004
SOMATOM CARE CONTRAST CT
K043087 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 37d
Cleared Nov 24, 2004
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
K043112 · General Electric Co.
LNH · System, Nuclear Magnetic Resonance Imaging · 14d
Cleared Nov 24, 2004
X-LEONARDO
K042995 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 23d
Cleared Nov 16, 2004
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
K043016 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 14d
Cleared Nov 10, 2004
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
K041818 · Boston Scientific Corp
ITX · Transducer, Ultrasonic, Diagnostic · 127d
Cleared Nov 09, 2004
GEMINI GXL
K042935 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 15d
Cleared Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617 · Siemens Medical Solutions USA, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 42d
Cleared Oct 29, 2004
C-PET PLUS IMAGING SYSTEM
K042839 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 15d
Cleared Oct 27, 2004
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K042833 · Siemens Medical Solutions USA, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 14d
Cleared Oct 20, 2004
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K042770 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 15d
Cleared Sep 24, 2004
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 39d
Cleared Sep 24, 2004
KODAK COLOR MEDICAL IMAGER 1000
K042159 · Eastman Kodak Company
LMC · Camera, Multi Format, Radiological · 45d
Cleared Sep 24, 2004
KODAK MEDICAL IMAGER 300
K042158 · Eastman Kodak Company
LMC · Camera, Multi Format, Radiological · 45d
Cleared Sep 08, 2004
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Sep 08, 2004
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
K042257 · General Electric Co.
KPS · System, Tomography, Computed, Emission · 19d
Cleared Aug 16, 2004
CYPRESS ULTRASOUND SYSTEM
K042055 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 17d
Cleared Aug 13, 2004
ACUSON CV70 CARDIOVASCULAR SYSTEM
K042044 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 14d
Cleared Jul 30, 2004
UNDECIDED
K041484 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 56d
Cleared Jul 29, 2004
GEMINI PET/CT IMAGING SYSTEM
K041955 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 8d
Cleared Jul 28, 2004
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co.
IZL · System, X-ray, Mobile · 12d
Cleared Jul 21, 2004
MAGNETOM ESPREE SYSTEM
K041112 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 84d
Cleared Jul 16, 2004
MAGNETOM C! MR SYSTEM
K041111 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 79d
Cleared Jul 08, 2004
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
K041688 · General Electric Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 16d
Cleared Jul 02, 2004
SOURCELINK
K041576 · C.R. Bard, Inc.
KXK · Source, Brachytherapy, Radionuclide · 21d
Cleared Jul 02, 2004
GE VIVID 7 BT04
K041552 · General Electric Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 23d

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All categories 4719 LLZ System, Image Processing, Radiological 718 IYN System, Imaging, Pulsed Doppler, Ultrasonic 532 LNH System, Nuclear Magnetic Resonance Imaging 408 JAK System, X-ray, Tomography, Computed 345 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