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
Cleared
Nov 20, 2002
6 CHANNEL BODY COIL
MOS
Coil, Magnetic Resonance, Specialty
27d
Cleared
Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Nov 18, 2002
GORE 3.0T TORSO ARRAY
MOS
Coil, Magnetic Resonance, Specialty
17d
Cleared
Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
KGI
Densitometer, Bone
30d
Cleared
Nov 08, 2002
ECAT LSO PET/CT 16
KPS
System, Tomography, Computed, Emission
18d
Cleared
Nov 08, 2002
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
MOS
Coil, Magnetic Resonance, Specialty
11d
Cleared
Nov 07, 2002
CENTRICITY PACS PLUS
LLZ
System, Image Processing, Radiological
15d
Cleared
Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
MUJ
System, Planning, Radiation Therapy Treatment
134d
Cleared
Nov 05, 2002
EXTRA LARGE BODY COIL
MOS
Coil, Magnetic Resonance, Specialty
21d
Cleared
Nov 05, 2002
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
LNH
System, Nuclear Magnetic Resonance Imaging
15d
Cleared
Nov 05, 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
11d
Cleared
Nov 04, 2002
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
MOS
Coil, Magnetic Resonance, Specialty
138d
Cleared
Oct 30, 2002
PHILIPS DIGITAL IMAGING OPTION RELEASE 1
LLZ
System, Image Processing, Radiological
15d
Cleared
Oct 30, 2002
PHILIPS MULTIDIAGNOST ELEVA
IZI
System, X-ray, Angiographic
15d
Cleared
Oct 25, 2002
REAL TIME HDR (220V), MODEL 132.001
JAQ
System, Applicator, Radionuclide, Remote-controlled
67d
Cleared
Oct 25, 2002
PHILIPS HARMONY RELEASE 1
LLZ
System, Image Processing, Radiological
64d
Cleared
Oct 25, 2002
VARISOURCE BREAST TEMPLATE SYSTEM
JAQ
System, Applicator, Radionuclide, Remote-controlled
28d
Cleared
Oct 24, 2002
SPOT PRO (220V), MODEL 131.099
MUJ
System, Planning, Radiation Therapy Treatment
66d
Cleared
Oct 24, 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
LLZ
System, Image Processing, Radiological
29d
Cleared
Oct 23, 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
JAK
System, X-ray, Tomography, Computed
16d
Cleared
Oct 22, 2002
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
78d
Cleared
Oct 22, 2002
DRYSTAR 5500
LMC
Camera, Multi Format, Radiological
20d
Cleared
Oct 17, 2002
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X
LLZ
System, Image Processing, Radiological
52d
Cleared
Oct 11, 2002
HITACHI ALTAIRE
LNH
System, Nuclear Magnetic Resonance Imaging
80d
Cleared
Oct 11, 2002
ACUITY RADIATION THERAPY SIMULATOR
KPQ
System, Simulation, Radiation Therapy
28d
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