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
12583 Radiology devices
Cleared
Dec 14, 2012
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
JAQ
System, Applicator, Radionuclide, Remote-controlled
88d
Cleared
Dec 14, 2012
PERCUNAV
JAK
System, X-ray, Tomography, Computed
207d
Cleared
Dec 13, 2012
PRESTO 1000 SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
23d
Cleared
Dec 13, 2012
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
30d
Cleared
Dec 13, 2012
VEX-S 100W INTRAORAL X-RAY SYSTEM
EHD
Unit, X-ray, Extraoral With Timer
34d
Cleared
Dec 13, 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
MOS
Coil, Magnetic Resonance, Specialty
30d
Cleared
Dec 13, 2012
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
LNH
System, Nuclear Magnetic Resonance Imaging
108d
Cleared
Dec 12, 2012
MOSAIQ ONCOLOGY INFORMATION SYSTEM
IYE
Accelerator, Linear, Medical
58d
Cleared
Dec 11, 2012
MAVRIC SL
LNH
System, Nuclear Magnetic Resonance Imaging
391d
Cleared
Dec 10, 2012
OP300
OAS
X-ray, Tomography, Computed, Dental
153d
Cleared
Dec 10, 2012
CARDNAV
OWB
Interventional Fluoroscopic X-ray System
314d
Cleared
Dec 07, 2012
VITESSE 3.0
MUJ
System, Planning, Radiation Therapy Treatment
59d
Cleared
Dec 07, 2012
DDRVERSA MOTION
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
71d
Cleared
Dec 07, 2012
DENTAL X-RAY Z70 (W)
EHD
Unit, X-ray, Extraoral With Timer
106d
Cleared
Dec 06, 2012
MRJ 3300
LNH
System, Nuclear Magnetic Resonance Imaging
148d
Cleared
Dec 05, 2012
ACUSON
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
12d
Cleared
Dec 05, 2012
LESSRAY
OWB
Interventional Fluoroscopic X-ray System
51d
Cleared
Dec 05, 2012
CALYPSO SYSTEM
IYE
Accelerator, Linear, Medical
61d
Cleared
Dec 05, 2012
CLARITY
IYE
Accelerator, Linear, Medical
183d
Cleared
Dec 03, 2012
ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
LLZ
System, Image Processing, Radiological
245d
Cleared
Nov 28, 2012
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
104d
Cleared
Nov 28, 2012
VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
LLZ
System, Image Processing, Radiological
111d
Cleared
Nov 21, 2012
.DECIMAL PHOTON BLOCK
IXI
Block, Beam-shaping, Radiation Therapy
54d
Cleared
Nov 21, 2012
PLANMED NUANCE DIGIGUIDE
MUE
Full Field Digital, System, X-ray, Mammographic
139d
Cleared
Nov 20, 2012
SYNGO.VIA
LLZ
System, Image Processing, Radiological
19d
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