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
12849 Radiology devices
Cleared
Dec 29, 1997
FLOSTAT VASCULAR REPORT GENERATOR (VRG)
JAF
Monitor, Ultrasonic, Nonfetal
81d
Cleared
Dec 23, 1997
LORAD M-III ELITE (M-III E)
IZH
System, X-ray, Mammographic
90d
Cleared
Dec 23, 1997
N.I.T., INC. NEEDLE GUIDING TEMPLATE
IWJ
System, Applicator, Radionuclide, Manual
90d
Cleared
Dec 23, 1997
FLOSTAT VASCULAR LAB
JAF
Monitor, Ultrasonic, Nonfetal
90d
Cleared
Dec 23, 1997
HARMONIC IMAGING WITH CONTRAST
IYO
System, Imaging, Pulsed Echo, Ultrasonic
82d
Cleared
Dec 22, 1997
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
286d
Cleared
Dec 22, 1997
AUKLET CT SCANNER, TSX-003A
JAK
System, X-ray, Tomography, Computed
69d
Cleared
Dec 22, 1997
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
LMD
System, Digital Image Communications, Radiological
67d
Cleared
Dec 22, 1997
LIGHTLINE-M
IZX
Collimator, Manual, Radiographic
40d
Cleared
Dec 22, 1997
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
EAM
Screen, Intensifying, Radiographic
28d
Cleared
Dec 18, 1997
DIGITAL ADD ON MULTI SYSTEM
KPR
System, X-ray, Stationary
80d
Cleared
Dec 17, 1997
KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM)
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
217d
Cleared
Dec 17, 1997
PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
190d
Cleared
Dec 17, 1997
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS
IYE
Accelerator, Linear, Medical
90d
Cleared
Dec 17, 1997
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
LMD
System, Digital Image Communications, Radiological
72d
Cleared
Dec 12, 1997
ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)
IYO
System, Imaging, Pulsed Echo, Ultrasonic
228d
Cleared
Dec 12, 1997
COMPACT OR COMP-X
IZL
System, X-ray, Mobile
170d
Cleared
Dec 12, 1997
SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM
LLZ
System, Image Processing, Radiological
78d
Cleared
Dec 12, 1997
MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
IZL
System, X-ray, Mobile
74d
Cleared
Dec 12, 1997
SMART MOTORIZED VIEWER
IXC
Illuminator, Radiographic-film
56d
Cleared
Dec 05, 1997
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
LMD
System, Digital Image Communications, Radiological
119d
Cleared
Dec 05, 1997
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
LMD
System, Digital Image Communications, Radiological
86d
Cleared
Dec 05, 1997
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
MOS
Coil, Magnetic Resonance, Specialty
72d
Cleared
Dec 05, 1997
CARBON FIBER CONFORMAL COUCH TOP
IXQ
Table, Radiographic, Stationary Top
58d
Cleared
Dec 04, 1997
AUTIMO 2.5-D AND AUTIMO 3-D
IXI
Block, Beam-shaping, Radiation Therapy
188d
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