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
12632 Radiology devices
Cleared
Dec 23, 2009
RADIONUCLIDE BRACHYTHERAPY SOURCE
KXK
Source, Brachytherapy, Radionuclide
28d
Cleared
Dec 23, 2009
O-SCAN MR SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
134d
Cleared
Dec 23, 2009
ZIEHM SOLO
OWB
Interventional Fluoroscopic X-ray System
138d
Cleared
Dec 15, 2009
ARIA RADIATION ONCOLOGY WITH MIRS
IYE
Accelerator, Linear, Medical
29d
Cleared
Dec 15, 2009
TIGRT IVS
IYE
Accelerator, Linear, Medical
118d
Cleared
Dec 11, 2009
DIGITAL LIGHTBOX
LLZ
System, Image Processing, Radiological
70d
Cleared
Dec 11, 2009
DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
LLZ
System, Image Processing, Radiological
217d
Cleared
Dec 11, 2009
GAMMALOC SYSTEM, MODEL 03-00001
IYX
Camera, Scintillation (gamma)
459d
Cleared
Dec 10, 2009
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
8d
Cleared
Dec 10, 2009
DISCOVERY MODEL NM/CT 670
KPS
System, Tomography, Computed, Emission
27d
Cleared
Dec 10, 2009
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
OBJ
Catheter, Ultrasound, Intravascular
108d
Cleared
Dec 10, 2009
PRESIDIO PACS
LLZ
System, Image Processing, Radiological
148d
Cleared
Dec 07, 2009
ALATUS VAGINAL BALLOON PACKING SYSTEM
JAQ
System, Applicator, Radionuclide, Remote-controlled
110d
Cleared
Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
57d
Cleared
Dec 02, 2009
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
LLZ
System, Image Processing, Radiological
97d
Cleared
Dec 02, 2009
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300
JAK
System, X-ray, Tomography, Computed
155d
Cleared
Dec 02, 2009
MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
MUH
System, X-ray, Extraoral Source, Digital
279d
Cleared
Dec 01, 2009
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Nov 30, 2009
TRILOGY MX
IYE
Accelerator, Linear, Medical
73d
Cleared
Nov 30, 2009
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
OWB
Interventional Fluoroscopic X-ray System
112d
Cleared
Nov 25, 2009
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
LNH
System, Nuclear Magnetic Resonance Imaging
125d
Cleared
Nov 24, 2009
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
JAD
System, Therapeutic, X-ray
266d
Cleared
Nov 20, 2009
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
10d
Cleared
Nov 20, 2009
ORTHOPANTOMOGRAPH OP30
MUH
System, X-ray, Extraoral Source, Digital
88d
Cleared
Nov 20, 2009
ACU007S
KXK
Source, Brachytherapy, Radionuclide
94d
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