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
12784 Radiology devices
Cleared
Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
IZH
System, X-ray, Mammographic
71d
Cleared
Jan 16, 2002
LOGIQBOOK
IYO
System, Imaging, Pulsed Echo, Ultrasonic
26d
Cleared
Jan 10, 2002
GE LOGIQ 5
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
29d
Cleared
Jan 08, 2002
EXTREMITY COIL
MOS
Coil, Magnetic Resonance, Specialty
70d
Cleared
Jan 07, 2002
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
17d
Cleared
Jan 02, 2002
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
IXK
System, Imaging, X-ray, Electrostatic
398d
Cleared
Jan 02, 2002
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
72d
Cleared
Dec 28, 2001
MAGNETOM TRIO SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
59d
Cleared
Dec 28, 2001
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
ITX
Transducer, Ultrasonic, Diagnostic
49d
Cleared
Dec 21, 2001
DIGIPAN / DPI
MUH
System, X-ray, Extraoral Source, Digital
137d
Cleared
Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
85d
Cleared
Dec 20, 2001
HAND-CARRIED ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
6d
Cleared
Dec 14, 2001
SHOULDER COIL
MOS
Coil, Magnetic Resonance, Specialty
51d
Cleared
Dec 13, 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
MOS
Coil, Magnetic Resonance, Specialty
51d
Cleared
Dec 11, 2001
INTERA I/T
LNH
System, Nuclear Magnetic Resonance Imaging
63d
Cleared
Dec 10, 2001
NURVO 9000 ENDOCAVITARY COILS
MOS
Coil, Magnetic Resonance, Specialty
194d
Cleared
Dec 07, 2001
NOMOS MOTORIZED CRANE II
JAI
Couch, Radiation Therapy, Powered
88d
Cleared
Dec 07, 2001
KODAK DIRECTVIEW TABLETOP CASSETTE
IXA
Cassette, Radiographic Film
30d
Cleared
Dec 06, 2001
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
MUH
System, X-ray, Extraoral Source, Digital
30d
Cleared
Dec 06, 2001
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
MUH
System, X-ray, Extraoral Source, Digital
30d
Cleared
Dec 05, 2001
FOCAL SIM
MUJ
System, Planning, Radiation Therapy Treatment
78d
Cleared
Nov 29, 2001
DRYSTAR, MODEL 4500M
LMC
Camera, Multi Format, Radiological
90d
Cleared
Nov 27, 2001
CARDIOVASCULAR ARRAY
MOS
Coil, Magnetic Resonance, Specialty
12d
Cleared
Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
85d
Cleared
Nov 20, 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
29d
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