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
Nov 20, 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
20d
Cleared
Nov 16, 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
11d
Cleared
Nov 15, 2001
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
OWB
Interventional Fluoroscopic X-ray System
15d
Cleared
Nov 14, 2001
ADC PEDIATRIC
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
90d
Cleared
Nov 13, 2001
SSA-770A, APLIO ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
8d
Cleared
Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
13d
Cleared
Nov 07, 2001
GEMINI IMAGING SYSTEM
JAK
System, X-ray, Tomography, Computed
15d
Cleared
Nov 07, 2001
SOMATOM P30 CT SYSTEMS
JAK
System, X-ray, Tomography, Computed
15d
Cleared
Nov 06, 2001
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
KPS
System, Tomography, Computed, Emission
15d
Cleared
Nov 02, 2001
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
KPR
System, X-ray, Stationary
14d
Cleared
Oct 31, 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
LNH
System, Nuclear Magnetic Resonance Imaging
89d
Cleared
Oct 31, 2001
MODIFICATION TO: ECAT LSO PET/CT SCANNER
KPS
System, Tomography, Computed, Emission
9d
Cleared
Oct 30, 2001
ULTRASOUND TRANSDUCER COVER
ITX
Transducer, Ultrasonic, Diagnostic
188d
Cleared
Oct 30, 2001
CARDIQ FUNCTION
JAK
System, X-ray, Tomography, Computed
15d
Cleared
Oct 26, 2001
ADVANCED LUNG ANALYSIS-1
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Oct 24, 2001
CAAS II QVA
LLZ
System, Image Processing, Radiological
83d
Cleared
Oct 18, 2001
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
JAA
System, X-ray, Fluoroscopic, Image-intensified
80d
Cleared
Oct 17, 2001
SEED SELECTRON MODEL V. 1.0
JAQ
System, Applicator, Radionuclide, Remote-controlled
287d
Cleared
Oct 16, 2001
HRH-63-8 HEAD ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
25d
Cleared
Oct 16, 2001
HAC-420 HEAD ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
11d
Cleared
Oct 05, 2001
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
JAK
System, X-ray, Tomography, Computed
9d
Cleared
Oct 01, 2001
DOSERIGHT
JAK
System, X-ray, Tomography, Computed
76d
Cleared
Sep 25, 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
MOS
Coil, Magnetic Resonance, Specialty
8d
Cleared
Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
LNH
System, Nuclear Magnetic Resonance Imaging
20d
Cleared
Sep 20, 2001
MODIFICATION TO LR 5200 FILM RECORDER
LMC
Camera, Multi Format, Radiological
85d
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