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
12789 Radiology devices
Cleared
May 15, 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
15d
Cleared
May 15, 2001
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
LNH
System, Nuclear Magnetic Resonance Imaging
61d
Cleared
May 04, 2001
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
May 02, 2001
ECLIPSE 6.5
IYE
Accelerator, Linear, Medical
30d
Cleared
Apr 17, 2001
FG-36UX, FIBER ULTRASOUND GASTROSCOPE
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
35d
Cleared
Apr 12, 2001
U04
OWB
Interventional Fluoroscopic X-ray System
14d
Cleared
Apr 11, 2001
FIESTA IMAGING OPTION
LNH
System, Nuclear Magnetic Resonance Imaging
197d
Cleared
Apr 10, 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
MUJ
System, Planning, Radiation Therapy Treatment
26d
Cleared
Apr 09, 2001
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
LNH
System, Nuclear Magnetic Resonance Imaging
42d
Cleared
Apr 06, 2001
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
ITX
Transducer, Ultrasonic, Diagnostic
14d
Cleared
Apr 05, 2001
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
LNI
System, Nuclear Magnetic Resonance Spectroscopic
79d
Cleared
Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
MOS
Coil, Magnetic Resonance, Specialty
132d
Cleared
Apr 03, 2001
MODEL 455GE PHASED ARRAY WRIST COIL
MOS
Coil, Magnetic Resonance, Specialty
84d
Cleared
Apr 02, 2001
PHILIPS BV LIBRA
OXO
Image-intensified Fluoroscopic X-ray System, Mobile
19d
Cleared
Mar 30, 2001
GE CT-PET SYSTEM
JAK
System, X-ray, Tomography, Computed
25d
Cleared
Mar 29, 2001
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
DQO
Catheter, Intravascular, Diagnostic
20d
Cleared
Mar 28, 2001
ADC QS/IPD WORKSTATION
LLZ
System, Image Processing, Radiological
30d
Cleared
Mar 15, 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
87d
Cleared
Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
IZH
System, X-ray, Mammographic
58d
Cleared
Mar 15, 2001
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
15d
Cleared
Mar 15, 2001
NEMIO
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
13d
Cleared
Mar 13, 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
LNH
System, Nuclear Magnetic Resonance Imaging
82d
Cleared
Mar 13, 2001
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
29d
Cleared
Mar 12, 2001
PHILIPS BV PULSERA/ENDURA
OWB
Interventional Fluoroscopic X-ray System
27d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices