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
12779 Radiology devices
8676–8700 of 12779
Cleared Oct 11, 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061 · Konica Minolta Medical & Graphic, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 25d
Cleared Oct 11, 2002
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
K023100 · General Electric Medical Systems Information Techn
LLZ · System, Image Processing, Radiological · 23d
Cleared Oct 11, 2002
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
K023130 · Mri Devices Corp.
LNH · System, Nuclear Magnetic Resonance Imaging · 21d
Cleared Oct 11, 2002
BBC-63-GE BREAST ARRAY COIL
K023164 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 18d
Cleared Oct 09, 2002
MODIFICATION TO FOCUS
K022630 · Instrumentarium Corp.
EHD · Unit, X-ray, Extraoral With Timer · 63d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207 · Toshiba America Medical Systems, In.C
LNH · System, Nuclear Magnetic Resonance Imaging · 14d
Cleared Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · Computerized Medical Systems, Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 277d
Cleared Oct 08, 2002
INNOVA AND INNOVA 2000 S
K022322 · Ge Medical Systems, Inc.
OWB · Interventional Fluoroscopic X-ray System · 83d
Cleared Oct 08, 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565 · Stereotaxis, Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 67d
Cleared Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · Canon, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 15d
Cleared Oct 03, 2002
CSV12 SOFTWARE VIEWER
K022896 · Acuson Corp.
LLZ · System, Image Processing, Radiological · 30d
Cleared Oct 03, 2002
QSC-63-INT SHOULDER ARRAY COIL SET
K022910 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 30d
Cleared Oct 01, 2002
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493 · Mentor Corp.
KPT · Calibrator, Dose, Radionuclide · 504d
Cleared Sep 27, 2002
HRK-63 KNEE ARRAY COIL
K022883 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 28d
Cleared Sep 26, 2002
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
K023020 · Agfa Corp.
IXA · Cassette, Radiographic Film · 15d
Cleared Sep 19, 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Sep 19, 2002
GE QUASAR NUCLEAR MEDICINE SYSTEM
K022960 · Ge Medical Systems F.I. Haifa
KPS · System, Tomography, Computed, Emission · 13d
Cleared Sep 12, 2002
ACQPLAN 5.0
K013644 · Philips Medical Systems, Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 311d
Cleared Sep 12, 2002
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K021276 · Pentax Precision Instrument Corp.
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 143d
Cleared Sep 12, 2002
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
K022292 · Agfa Corp.
LLZ · System, Image Processing, Radiological · 59d
Cleared Sep 12, 2002
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co.
KPS · System, Tomography, Computed, Emission · 14d
Cleared Sep 06, 2002
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · Pentax Precision Instrument Corp.
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 137d
Cleared Sep 06, 2002
KUSKE BREAST APPLICATOR SET, MODEL 189.006
K022635 · Nucletron Corporation
JAQ · System, Applicator, Radionuclide, Remote-controlled · 29d
Cleared Sep 06, 2002
LR DICOM CONTROLLER
K022658 · Agfa Corp.
LMC · Camera, Multi Format, Radiological · 28d
Cleared Sep 06, 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669 · GE Medical Systems
MOS · Coil, Magnetic Resonance, Specialty · 25d

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All categories 12779 LLZ System, Image Processing, Radiological 2030 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1123 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 681 IYE Accelerator, Linear, Medical 582 MOS Coil, Magnetic Resonance, Specialty 454 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 346 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 313 KPR System, X-ray, Stationary 291 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192