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
12831 Radiology devices
Cleared
Jan 18, 2000
LUMAGEM SCINTILLATION CAMERA
IYX
Camera, Scintillation (gamma)
69d
Cleared
Jan 18, 2000
PHASED ARRAY KNEE AND FOOT COIL
MOS
Coil, Magnetic Resonance, Specialty
50d
Cleared
Jan 14, 2000
PHARMASEED, MODEL BT-103-1
KXK
Source, Brachytherapy, Radionuclide
213d
Cleared
Jan 14, 2000
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
LNH
System, Nuclear Magnetic Resonance Imaging
23d
Cleared
Jan 13, 2000
ITP, MODEL 1.0
MUJ
System, Planning, Radiation Therapy Treatment
176d
Cleared
Jan 12, 2000
SEGMENTED VAGINAL APPLICATOR
JAQ
System, Applicator, Radionuclide, Remote-controlled
90d
Cleared
Jan 10, 2000
AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
JAI
Couch, Radiation Therapy, Powered
84d
Cleared
Jan 06, 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
JAQ
System, Applicator, Radionuclide, Remote-controlled
90d
Cleared
Dec 30, 1999
THERMOCHEM-HT SYSTEM
MLW
Warmer, Peritoneal Dialysate
87d
Cleared
Dec 29, 1999
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
LLZ
System, Image Processing, Radiological
90d
Cleared
Dec 29, 1999
INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
LLZ
System, Image Processing, Radiological
85d
Cleared
Dec 28, 1999
CADENCE DOPPLER ULTRASOUND SYSTEM
KNG
Monitor, Ultrasonic, Fetal
246d
Cleared
Dec 28, 1999
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
LLZ
System, Image Processing, Radiological
50d
Cleared
Dec 23, 1999
OMNICORDER BIOSCAN SYSTEM
LHQ
System, Telethermographic (adjunctive Use)
316d
Cleared
Dec 23, 1999
PHARMASEED, MODEL BT-125-1
KXK
Source, Brachytherapy, Radionuclide
191d
Cleared
Dec 23, 1999
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
49d
Cleared
Dec 21, 1999
PHILIPS INTURIS DICOM RECORDER
LLZ
System, Image Processing, Radiological
85d
Cleared
Dec 21, 1999
RAPTOR TREATMENT PLANNING SYSTEM
IYE
Accelerator, Linear, Medical
76d
Cleared
Dec 21, 1999
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
JAK
System, X-ray, Tomography, Computed
54d
Cleared
Dec 21, 1999
DIGITEC TWO STAGE COMPRESSION KIT
IZH
System, X-ray, Mammographic
50d
Cleared
Dec 21, 1999
UROVIEW 2800
OWB
Interventional Fluoroscopic X-ray System
50d
Cleared
Dec 21, 1999
KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY
IZI
System, X-ray, Angiographic
29d
Cleared
Dec 21, 1999
PENSIL TRAUMA, MODEL WWS6100
KPR
System, X-ray, Stationary
57d
Cleared
Dec 20, 1999
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
17d
Cleared
Dec 15, 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
DQO
Catheter, Intravascular, Diagnostic
131d
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